Acceptability and feasibility of HIV self-testing in Southeast Asia: A scoping review

Abstract

Background

HIV self-testing (HIVST) policies in Southeast Asia are under development. This scoping review aimed to systematically synthesize the available literature on the acceptability and feasibility of HIVST in Southeast Asia.

Methods

Systematic search was conducted on January 20, 2022, in eight databases: PubMed/MEDLINE, CINAHL, Web of Science, Academic Search Complete, SocINDEX, PsycINFO, PsycArticles, and CENTRAL. Acceptability (HIV testing frequency, willingness to pay, use, and recommend the test, ease of use, preference over standard tests, and partner testing) and feasibility (error rate, readability, and diagnostic performance) parameters were followed for the inclusion of articles. A narrative synthesis was done to present findings from included studies on the acceptability and feasibility of HIVST.

Results

A total of 5091 records were identified through database search, and 362 were deleted after deduplication. The screening process resulted in 18 studies that met the inclusion criteria. Results indicated a high acceptability rate due to convenience, increasing awareness about HIVST, availability, and affordability of test kits, and confidentiality of test results. A high feasibility rate was reported due to a low occurrence of errors in self-testing, interpretability of results, and a low percentage of invalid and false-reactive results. Issues identified include costs of HIVST for individual use, distribution mode, type of supervision, counseling, geographic location, and socioeconomic status.

Conclusions

Evidence supports the acceptability and feasibility of HIVST in Southeast Asia. There is a need to regulate and license HIVST in Southeast Asia to have better recognition as a supplement to HTS.

Keywords

Acceptability feasibility HIV HIV self-testing human immunodeficiency virus Southeast Asia

Introduction

By the end of 2020, about 37.7 million people were living with HIV in the world.¹ The Joint United Nations Programme on HIV/AIDS (UNAIDS) reported that the key populations of HIV accounted for 65% of HIV infections in 2020. These key populations include female sex workers (FSW), men who have sex with men (MSM), gay men, transgender people, people who inject drugs (PWID),¹ heterosexuals,² pregnant women, and teenagers.³

UNAIDS has established an intermediate goal to end the HIV/AIDS epidemic by 2020. This goal targets to have 90% of people living with HIV be diagnosed and aware of their status, 90% of those diagnosed individuals should be on antiretroviral therapy (ART), and 90% of those being treated with ART should be virally suppressed by 2020. However, based on UNAIDS's unique analysis in 2020,⁴ 84% of people living with HIV know their status, 73% of those who know their status are on treatment, and 63% of those on treatment are virally suppressed. Despite the significant progress, the 90-90-90 initiative was not achieved; hence, UNAIDS launched the 95-95-95 targets to end the AIDS epidemic by 2030. Combined with primary prevention targets, UN member states should focus their attention on supporting enablers, bridging inequalities in treatment coverage and outcomes, and accelerating reductions of HIV incidence in all sub-populations, age groups, and geographic areas.⁵

HIV testing policies differ across countries. Although it is open for every individual, HIV testing is more recommended to key populations or for those located in high-prevalence areas.⁶ In 2016, the World Health Organization (WHO) released a supplemental guideline about HIV self-testing (HIVST) to scale up and provide support to the consolidated guidelines about HIV testing services (HTS) released in 2015.⁷ HTS encompasses a wide range of services from HIV testing, counseling, prevention, diagnosis, treatment, care, support, and quality assurance. However, gaps were identified in the delivery of HTS including the gender-biased location of HTS which is more comfortable and appropriate for women compared to men, poor approaches for early diagnosis and timely referral for infants, low HIV testing coverage in children and adolescents, poor quality of HTS in low resource settings leading to the inaccurate result of the diagnosis, and the HTS in countries with low HIV prevalence does not reach the key population. HIVST was one of the approaches recommended by WHO in 2016 to address the current gaps and limitations in HTS.⁸

HIVST was first introduced and proposed as an alternative to the traditional HIV testing method in 1986. However, it was only in 2012 when the OraQuick® In‐Home HIV Test, the first US FDA-approved HIVST product became available.⁹ Even though there is already an HIVST product available, the WHO could not recommend it yet due to the lack of evidence that could support the HIVST introduction.⁹ Through the WHO recommendation, HIVST is used as an approach for improved HTS delivery.⁸

HIVST may be done in two ways: saliva or blood test. It involves individual specimen collection by using a simple, rapid HIV test. The results are then read by the person who performed the test.¹⁰ The process of HIVST can be either supervised or unsupervised. Supervised HIVST involves a trained provider who will assist the individual in the proper process of self-testing. Meanwhile, unsupervised HIVST is when the individual does the self-test process alone and only involves manufacturer-provided instructions. The distribution of HIVST can be through community, facility, community and facility integration, internet-based, and pharmacy-based.⁷

An estimated 3.5 million people living with HIV (PLHIV) are from Southeast Asia.⁶ The HIV epidemics occurring in the Southeast Asia remain a major public health concern since the region has the second-largest HIV burden after sub-Saharan Africa.⁶ Southeast Asian countries are classified into lower-middle (Cambodia, Indonesia, Laos, Myanmar, the Philippines, Timor-Leste, and Vietnam), upper-middle (Malaysia and Thailand), and high-income economies (Brunei and Singapore).¹¹ Despite the different methods of HIV testing and the development of HIVST policies, the majority of lower-middle-income economies contributed significantly to the incidence and prevalence of HIV.^12,13 This is because of the different challenges posed in those countries that the key population faces including suboptimal policy implementation and unfriendly testing facilities¹⁴ as well as various barriers such as stigma, discrimination, cultural norms,¹² shame, embarrassment, fear of positive diagnosis resulting in social exclusion,¹³ and confidentiality issues.¹⁴ HIVST is an innovative method that can reach and address these challenges faced by the key populations.¹⁰

Southeast Asian countries with HIVST policies under development include Indonesia, Malaysia, Myanmar, Philippines, Singapore, and Thailand.¹⁰ Brunei has no policy regarding HIVST,¹⁵ while in Timor-Leste, the status of their HIVST policy is unknown.¹⁶ In Cambodia, HIVST are available to people with high HIV risk such as sero-discordant couples and key populations who are hard-to-reach or never been reached by peer outreach workers.¹⁷ The key populations in Vietnam can access HIVST kits and information at 20 civil society organizations (CSOs) and through online mail order. HIVST is delivered through key population-led CSOs and partner distribution as part of index testing.¹⁸ And in Laos, the National Strategy and Action Plan for HIV/AIDS calls for the introduction of HIVST kits, which is currently used by the key populations in a CSO program setting on a pilot basis.¹⁹

While there have been reviews on HIVST, most of them only focused on the acceptability of HIVST^20–22 which had examined studies mostly from high-income countries among MSM^21,22 and countries from Africa (Kenya and Malawi).²² Only one scoping review was found to discuss the acceptability of HIVST which was conducted in sub-Saharan Africa.²⁰ There was also only one review found to discuss both acceptability and feasibility of HIVST³ wherein 75% of their gathered studies came from Africa and the remaining studies came from America and Asia. As there were no previous reviews found to focus on Southeast Asia, there is a need to explore the factors affecting acceptability and feasibility of HIVST in this area which consist mostly of lower-middle income countries.

Considering that HIVST policies in most Southeast Asian countries are still developing and have not been implemented, a scoping review is appropriate to systematically collect and summarize the available literature regarding the following research questions: (1) how is HIV self-testing recognized and accepted by the key population as an alternative method for detecting HIV infection in Southeast Asia?; and (2) what factors contribute to the acceptability and feasibility of HIVST among these populations? The synthesis of the collected data relevant to this topic contributes to identifying and addressing the gaps in knowledge to provide future research directions, probable steps, and policies intended to increase HIV screening rates and early detection and diagnosis of HIV.

Methods

This scoping review is conducted in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) 2020 Checklist²³ (Supplementary file 1). The authors developed and registered a protocol in the Open Science Framework (Supplementary file 2).²⁴

Selection criteria

Population/participants

Key population of HIV (e.g., FSW, MSM, PWID, among others).

Intervention

HIVST involves individual specimen collection (saliva or blood) by using a rapid HIV test. The individual can choose where he/she wants to perform the test. HIVST can be delivered to individuals through community-based, facility-based, pharmacy-based, online and secondary distribution. In these types of settings, the individual may perform the test with or without supervision (supervised or unsupervised).

Comparison

Approaches to HTS other than HIVST. Studies on the intervention that do not contain a reference to the comparison group were included in this scoping review.

Outcome

Acceptability and feasibility of HIVST. The operational definitions of these outcomes are guided by the study of Rivera et al.³ and Tonen-Wolyec et al.²⁵ The acceptability of HIVST was examined by the following parameters: number of first-time testers, willingness to pay, use, and recommend the test, ease of use, and preference over other HTS. HIVST used to test participants’ partners or friends were also included in the synthesis.

On the other hand, feasibility was examined by the following parameters: error rate, readability, and diagnostic performance of HIVST. Readability was the term used to describe the participants’ ability to interpret their results after HIVST. The error rate was calculated by the number of invalid results due to the error from the process of self-testing by participants. The diagnostic performance of the HIVST kit was measured by its reactivity rate and accuracy of test results.

Setting

Southeast Asia.

Context

Publications written in the English language and published from the start date of December 1, 2016, to January 20, 2022. Studies were limited to the analysis made to Southeast Asian countries.

Types of sources

This scoping review utilized records including original research articles, editorials, other reviews, and gray literature that are relevant to the acceptability and feasibility of HIVST.

Search strategy

The first two authors (K.B.C. and J.M.E.) developed the search strategy. The search strategy included search terms involving the key population, HIVST, outcomes on the acceptability and feasibility of HIVST, and Southeast Asian countries (Supplementary file 3). Date restrictions were employed wherein it must include articles published from December 1, 2016, the date when HIVST was recommended by the WHO, to the screening date of January 20, 2022. The supervisor (R.R.C.) searched the articles in the following databases: PubMed/MEDLINE, CINAHL, Web of Science, Academic Search Complete, SocINDEX, PsycINFO, PsycArticles, and CENTRAL. Gray literature search was performed through Avert, Rural Health Information Hub, The Global Fund, The UNAIDS, The World Bank, and WHO. Potential articles that were hand-searched from reference lists were included for full-text screening. To facilitate the process of selecting articles, the search records were uploaded to a reference management tool (Endnote web).

Information sources

The researchers utilized data and information from open access and subscription databases that were included in the search strategy. References that came from gray literature were searched manually through Google custom search engines.

Study selection and data extraction

The initial search results were exported to the Endnote web for de-duplication and screening. Four authors (J.M.E., K.B.C., K.M.M., and M.I.R.) independently performed title and abstract screening based on inclusion criteria in a blinded, standardized manner. For the articles that passed the initial screening, the last name of the first author, article title, and the source of the research article were collected for full-text screening. The reasons for the exclusion of studies can be found in Supplementary file 4. Afterward, the following information was extracted from the included articles: the last name of the first author of the study, publication year, country, settings, study design, population, intervention, type of specimen, type of supervision, comparator, and outcomes related to acceptability and feasibility of HIVST. For qualitative studies, we extracted the themes relevant to acceptability and feasibility. While for quantitative studies, we extracted the rates, proportions, and effect sizes. At least two authors were involved in the data selection and extraction from the studies. Conflicts encountered were resolved through the formation of a consensus or consultation with the research supervisor (R.R.C.).

Data charting and presentation

The researchers arranged the collected data according to their study characteristics such as the population, study design, geographic location, method of HIV testing, and reported outcomes (Table 1). A narrative synthesis was undertaken to present findings from included studies on the acceptability and feasibility of HIVST. This approach has been proven useful in synthesizing evidence of different types (qualitative, quantitative, economic, among others).²⁶ The results of the study were presented and discussed wherein it shall provide implications for HIVST as an alternative method for the detection of HIV infection and contribute to future research and HIV policies. Quality appraisal was not performed as a scoping review provides an overview of the relevant literature regardless of its risk of bias.

Table 1.

Characteristics of included studies reporting acceptability of HIVST.

Study	Study design	Study setting	Study population	Sample size	Intervention/Exposure	Comparator	Reported outcomes
Girault, 2021 Thailand	Cross-sectional	Metropolitan areas of Bangkok, Chiang Mai, and Pattaya cities	Thai MSM and TGW reached through community-based outreach activities	1432 MSM and 1092 TGW	OraQuick^® HIV self-test (oral-based HIVST)	Those who were referred to community- or facility-based HIV testing services	A total of 2486 participants (99.3%) selected HIVST versus other HTS. There were 34.5% MSM and 38.3% TGW who were first-time testers. About two-thirds of MSM (945 of 1422, 66.5%) and TGW (752 of 1082, 69.5%) showed interest in oral-based HIVST while 70 of 1422 MSM (4.9%) and 51 of 1082 TGW (4.7%) preferred blood-based HIVST. Less than 2% of both MSM & TGW participants showed no interest in performing HIVST in the future. The analysis of the study suggests that the most suitable price for an HIVST kit would be between 250 and 300 Thai baht (US$7.70–$9.30). Three-fourths of participants (1,332/1,786, 74.6%) would prefer a community-based facility that offers no charge for HIVST if HIVST prices were too high
Gohil, 2020 Philippines	Qualitative	Metro Manila	Key informants (program implementers, non-governmental organizations, doctors and academics, service providers and members associated with reference laboratories for HIV), MSM and TGW aged over 18 years	15 key informants, 42 target users of HIVST	HIVST	No comparison group	Key informants, MSM and TGW indicated that a high price would limit the access for HIVST. Majority of MSM and TGW were willing to use HIVST in the future
Green, 2016 Vietnam	Cross-sectional	Ho Chi Minh City, Can Tho, Nghe An, Hanoi, Hai Phong and Dien Bien in Vietnam	PWID, FSW, MSM	1296 PWID, 1248 FSW and 1528 MSM	HIVST	No comparison group	Among the participants, 55.6% FSW, 63.8% MSM and 69.3% PWID had intention to use HIVST when available. Privacy (74.4%), confidentiality (63.7%) and receiving a rapid result (49.5%) were the primary reasons for choosing HIVST. As for the user test preference, 49% FSW, 46.7% MSM and 28.3% PWID opted for an oral HIVST, while 42.9% FSW, 36.7% MSM and 59% PWID chose the rapid blood-based assay. Majority of the participants that intend to use HIVST were willing to pay for it (73.4% PWID, 82% FSW and 86.4% MSM). Between the three key populations of the study, the willingness to pay for HIVST of MSM had a significantly higher maximum price (US$5.4) than FSW (US$4.3) and PWID (US$3.9)
Green, 2017 Vietnam	Cohort	Ho Chi Minh City and Hanoi in Vietnam	MSM, PWID, PWID-sex partners, FSW	3155	Alere Determine^TM HIV-1/2 (blood-based HIVST) and OraQuick Rapid HIV-1/2 (oral-based HIVST)	No comparison group	Among the participants, 87.5% FSW, 51.3% MSM, 73.5% PWID, 73.5% Sex partners with a total percentage of 54.7% were new or first-time testers. Participants who used Alere Determine^TM HIV-1/2 (63.6%) and those who used OraQuick Rapid HIV-1/2 (20.9%) reported difficulty with application
Green, 2018 Vietnam	Cross-sectional	Community- based organization (CBO)	MSM	1351	Alere Determine^TM HIV Self-Test (blood-based HIVST) and OraQuick^® HIV Self-Test (oral-based HIVST)	No comparison group	There were 320 (57.9%) MSM under assisted HIVST and 412 (51.3%) MSM under unassisted HIVST who were first-time testers. There were 85.4% MSM under assisted HIVST and 94.8% under unassisted HIVST who were willing to use HIVST in the future. There were MSM under unassisted HIVST preferred to be assisted by CBO staff (57.2%). 21% of MSM preferred to self-test alone inside the CBO office while 16.6% wanted to self-test at home
Nguyen, 2019 Vietnam	Cohort	Thai Nguyen and Can Tho	MSM, PWID, FSW, partners and children of PLHIV	3978	SD Bioline HIV1/2 3.0 and SD Bioline HIV/Syphilis duo (blood-based HIVST) and OraQuick^® HIV Self-Test (oral-based HIVST)	No comparison group	There were 2654 (66.7%) participants who were first-time testers. The reasons for participants in accessing community-led HIVST include hesitation to go to a health facility, ensuring the confidentiality of results, convenience, cost-free, and comfortability
Pal, 2016 Cambodia	Qualitative	Cambodia	TGW, MSM, FSW	144	HIVST	No comparison group	Participants shared their willingness to get tested if the kits provided will be free and stated a price ranging from 1.25 USD to 10 USD is considered cost-effective. They also stated how oral testing is more feasible than blood for those who are afraid of needles
Phanuphak, 2018 Thailand	Cohort	Thailand	TGW, MSM	571	HIVST	No comparison group	Among the 571 participants, 46.9% reported the convenience of getting tested, 19.14% on the test’s privacy and provided confidentiality, 16.9% on the service’s selflessness, and 15.6% on the relevance of the service
Phanuphak, 2020 Thailand	Cohort	Thailand	TGW, MSM	564	HIVST	Offline HIV counseling and testing (Offline group), online pre-test counseling and offline HIV testing (Mixed group), online counseling and online, supervised, HIVST (Online group)	177 participants who were first-time testers chose Offline counseling (45.3%), followed by Online counseling (40.1%) and Mixed counseling having 14.5%. MSM and TGW participants who also chose online testing shared their fear of coming across a familiar person when getting tested in a physical clinic than those participants who chose the offline setting
Phongphiew, 2021 Thailand	Cross-sectional	Thailand	YMSM, YTGW	90	Fourth generation HIV test (Elecsys)	HIV antibody	38% of the participants shared their willingness to pay less than 6 USD for HIVST, while 34% and 28% stated their willingness to pay 6 to 10 USD and more than 10 USD, respectively, no association with their weekly income. Participants also shared their willingness to use HIVST due to its ease of use and quick process (46%, 36%). Participants within the age range of 15 to 18 showed their willingness to use HIVST one more time than those older than 18 years old
Piamonte, 2020 Philippines	Prospective cohort	Mandaluyong City, Metro Manila, Philippines	MSM	250	HIVST	No comparison group	Around 87% MSM reported willingness to buy HIVST kits and among those willing to buy, 78% preferred to perform it through oral swabs. The participants were willing to pay 500 Pesos or approximately 10 USD for the kit. Many MSM showed interest in buying HIVST kits if it is low-cost and saliva-based
Shrestha, 2020 Malaysia	Cross-sectional	Malaysia	MSM	577	HIVST	No comparison group	Higher acceptability of HIVST was reported if the kit would be offered for free. The privacy offered by HIVST greatly influenced the participants' preference over standard tests. Participants’ willingness to use HIVST increased significantly based on their ethnicity, sexual orientation, previous anal sex engagement for the past 6 months, prior HIV testing, and previous use of HIVST. There were 29.6% MSM first-time testers
Shrestha, 2020 Malaysia	Cross-sectional	Malaysia	TGW	361	HIVST	Traditional venue-based HIV testing	Almost half of the participants (47.6%) said they would be willing to use HIVST. Among those who expressed their willingness, 85.5% of them preferred to know the test results immediately while the remaining 14.5% preferred to mail their samples to the testing facilities and know the test results via mail. In this study, a multivariable analysis determined that the participants’ willingness to use HIVST was greatly associated with them having experienced sexual assault as a child and used of mobile phones and applications to find sex work clients
Tan, 2021 Singapore	Qualitative	Singapore	HSM	35	HIVST Oraquick (Oral fluid-based kit); BioSure (Blood-based kit)	No comparison group	This study revealed that most men preferred HIVST due to the privacy and anonymity it offers compared to the other HIV testing services. A blood-based kit was favored for higher accuracy, while the oral-fluid-based kit was favored for its convenience and ease of use
Wirtz, 2017 Myanmar	Qualitative	Myanmar	MSM, TGW	35	HIVST	HIV testing	The ease of testing at a time and location that was convenient for MSM and TW is considered a benefit of HIVST thus influencing the participants’ acceptability
Wirtz, 2021 Myanmar	Mixed methods	Myanmar	MSM, TGW	544	Unassisted HIVST	Community-based HIV testing services	Most of the participants (94%) reported that they would most likely have a test on a regular basis if they could use HIVST. Participants described the use of HIVST as an easy procedure that can be conducted at their preferred time and location. There were 64.7% MSM and TGW under HIVST that were first-time testers
Wulandari, 2019 Indonesia	Qualitative	Bali, Indonesia	MWPS	29	HIVST	No comparison group	The participants were willing to do HIV self-testing such as oral HIVST due to the simplicity, privacy, and confidentiality of the results compared to clinic-based testing
Wulandari, 2020 Indonesia	Cohort	Bali, Indonesia	MWPS	292	HIVST: OraQuick® ADVANCE Rapid HIV-1/2 Antibody Test	Assisted and Unassisted HIVST	Majority of participants (88.8%) would be likely or very likely to test themselves. There were 63.3% that would recommend HIVST to partners. Almost all (97.3%) reported that it was easy for them to do HIVST at brothels and over 99% participants stated each individual step was easy or very easy. Furthermore, 93% of participants said they would purchase the HIVST kit at the price of IDR 50,000 (US$3.5) or below. Participants were less likely to accept HIVST if they feared being diagnosed with HIV.

FSW, female sex workers; HIVST, HIV self-testing; HSM, heterosexual men; HTS, HIV testing services; MSM, men who have sex with men; MWPS, men who purchase sex; PLHIV, people living with HIV; PWID, people who inject drugs; TGW, transgender women; YMSM, young men who have sex with men; YTGW, young transgender women.

Results

A total of 5091 records were identified through database search. After deduplication, 362 records were removed, and 4609 records were excluded after the title and abstract screening. The full-text screening was performed in the remaining 120 records wherein 1 of the records was not retrieved. The screening process resulted in the exclusion of 104 reports for reasons stated in Figure 1. The remaining 15 reports identified via databases were included in this scoping review. On the other hand, 15 records were identified and retrieved from reference lists. No records were identified from the gray literature searches. After screening, 12 reports were excluded for reasons also outlined in Figure 1 whereas three reports identified via other methods were included. A total of 18 studies were included in this scoping review. Characteristics of the included studies are shown in Tables 1 and 2.

Table 2.

Characteristics of included studies reporting feasibility of HIVST.

Study	Study design	Study setting	Study population	Sample size	Intervention/Exposure	Comparator	Reported outcomes
Girault, 2021 Thailand	Cross-sectional	Metropolitan areas of Bangkok, Chiang Mai, and Pattaya cities	Thai MSM and TGW reached through community-based outreach activities	1432 MSM and 1092 TGW	OraQuick HIV Self-Test	Those who were referred to community- or facility-based HIV testing services	Only 4 (3.1%) of the participants were not able to interpret their HIVST results. There were 4 (0.3%) MSM under assisted and 2 (0.8%) MSM under unassisted HIVST that had an invalid test result. Only 1 (0.1%) TGW under assisted HIVST had an invalid test result. The reactivity rate among MSM who opted for unassisted HIVST was 9.6% whereas those who opted for assisted HIVST was 6.2%. The reactivity rate among TGW who opted for assisted HIVST was 7.3% whereas those who opted for unassisted HIVST was 2.4%
Gohil, 2020 Philippines	Qualitative	Metro Manila	Key informants (program implementers, non-governmental organizations, doctors and academics, service providers and members associated with reference laboratories for HIV), MSM and TGW aged over 18 years	15 key informants, 42 target users of HIVST	HIVST	No comparison group	A key informant (male doctor) indicated that accuracy of the test kit is important for the result may pose great implications for the patient. Blood-based HIVST was perceived to be more accurate by over half of MSM and TGW. Key informants, MSM and TGW indicated that counseling is important in HIVST to guide the patient on the steps after conducting HIVST.
Green, 2017 Vietnam	Cohort	Ho Chi Minh City and Hanoi in Vietnam	MSM, PWID, PWID-sex partners, FSW	3155	Alere Determine^TM HIV-1/2 (blood-based HIVST) and OraQuick Rapid HIV-1/2 (oral-based HIVST)	No comparison group	From a certain period (May 2016 to March 2017), 6.7% tested HIV reactive (in comparison to conventional public testing sites which only has 0.9%), 88% received confirmation testing and 96% were enrolled in ART. There was a high (97.2%) HIV test result concordance between the observer and self-tester for both tests
Green, 2018 Vietnam	Cross-sectional	Community- based organization	MSM	1351	Alere Determine^TM HIV Self-Test and OraQuick^® HIV Self-Test	No comparison group	There were 297 (7%) MSM who tested HIV-reactive and 269 (90.6%) were confirmed to be HIV-positive
Nguyen, 2019 Vietnam	Cohort	Thai Nguyen and Can Tho	MSM, PWID, FSW, partners and children of PLHIV	3978	SD Bioline HIV1/2 3.0 and SD Bioline HIV/Syphilis duo (blood-based HIVST) and OraQuick^® HIV Self-Test (oral-based HIVST)	No comparison group	There were 245 (6.2%) participants who tested HIV-reactive and 231 (5.8%) were confirmed to be HIV-positive
Pal, 2016 Cambodia	Qualitative	Cambodia	TGW, MSM, FSW	144	HIVST	No comparison group	FEW participants shared the accuracy of blood-based tests, but reconsidered the convenience of oral-based tests for people who are afraid of using needles. Meanwhile, MSM, TGW, and FSW patients shared their decision on taking care more of their health if test results turn positive like considering visiting healthcare centers, counseling, and taking ARTs
Phanuphak, 2018 Thailand	Cohort	Thailand	TGW, MSM	571	HIVST	First time and non-first-time testers	MSM and TGW participants reported their concerns regarding the diagnostic interpretation of online testing with regards to its quality patient care and the desire to inquire for confirmatory testing and ART.
Phanuphak, 2018 Thailand	Cohort	Thailand	TGW, MSM	564	HIVST	Offline, mixed, and online groups	Out of 36 participants from MSM and TGW key informants, 76% who tested positive through online, supervised HIVST agreed with a confirmatory testing, revealing that all of them (100%) are HIV-positive
Phongphiew, 2021 Thailand	Cross-sectional	Thailand	YMSM, YTGW	90	Fourth generation HIV test (Elecsys)	HIV antibody tests	The diagnostic performance of participants included in the study reported 2 (2.2%) positive, 21 (23.4%), and 67 (74.4%) for invalid and negative results, respectively. Reasons for the inclusion of invalid results are inadequate blood sample volumes, spillage of buffers, and errors on procedures (80.9%, 14.3%, 4.8%). One negative result was corrected after using the 4th gen HIV test, showing that the participant was HIV-positive. Two participants incorrectly interpreted their results as negative. The study also showed that teens ages 15 to 19 showed eagerness on getting blood-based testing while 23% resulted with an invalid outcome due to the technical skills when performing the blood test, in comparison with the Kenyan journal, having only 1.26% invalid results due to insufficient blood samples. Few mistakes and invalid results reported from YMSM and YTGW who were given an instructional video than those who were instructed verbally
Shrestha, 2020 Malaysia	Cross-sectional	Malaysia	MSM	544	HIVST	No comparison group	Participants from the study have expressed their strong preference for blood-based tests using a fingerstick. This may be due to the perceived accuracy and less false–negative test results. This study may have identified a preference, but it did not explicitly state the participants were opposed to saliva-based testing — the only HIVST kit prequalified by WHO to date
Tan, 2021 Singapore	Qualitative	Singapore	HSM	35	HIVST Oraquick (Oral fluid-based kit); BioSure (Blood-based kit)	No comparison group	In terms of accuracy, participants preferred blood-based kits over oral fluid-based kits. BioSure was the brand of the blood-based kit used in the study and despite the fact that it was more costly and invasive, most men still chose BioSure due to its higher accuracy of 99.7%. On the other, OraQuick, the brand of the oral fluid-based kit used was favored less due to its 91% accuracy which was perceived to be low compared to BioSure
Wirtz, 2021 Myanmar	Mixed methods	Myanmar	MSM, TGW	577	Unassisted HIVST	Community-based HIV testing services	A randomized trial and explanatory mixed methods were conducted in this study wherein participants were enrolled randomly to unassisted HIVST or community-based HIV testing services. Two HIVST-assigned participants reported having positive screening results and were referred to confirmatory testing. In terms of the readability of the test kits, 99.4% of the population who used HIVST understood the result of their test. 83.8% were found to be negative from the self-reported result of HIVST, 14.6% were found to be positive from the self-reported result of HIVST and 1.6% do not know their result

Acceptability

HIVST was acceptable among key populations. Common identified reasons for a high acceptability rate from the seven acceptability parameters include convenience,^14,27–31 increasing awareness about HIVST, availability, and affordability of test kits^27,32,33 and confidentiality of test results.^14,27,28,32

Willingness to use and ease of use

Among the thirteen studies on willingness to use and seven on ease of use, one study conducted in Cambodia reported that MSM and TGW participants were motivated to try the testing kits after being educated about HIVST through a video procedure.²⁷ MSM and TGW showed their satisfaction with supervised HIVST. They outlined that fear of meeting familiar people while attending offline facilities is their barrier to getting tested.³⁴ The MSM key population were more likely to get tested for HIVST depending on their sexual orientation, race, anal intercourse with a man and use of a testing kit 6 months prior, history of sexual trauma, and the use of mobile apps for sex work.^32,33 Meanwhile, TGW participants opted to receive their results in an instant while others preferred to send their testing samples and receive their results via mail.³⁵ HIVST could possibly increase the number of testing facilities conducted by NGOs and community clinics.³⁰

Preference over standard tests

Participants from 10 studies preferred HIVST over other HTS due to the same factors that influenced their willingness to use it.^14,27–29 HIVST offers a more convenient process of testing than other HTS.^14,33 The majority of studies showed that most participants preferred saliva-based testing^{14,27,32,36,37} over a blood-based assay.^33,38 In those studies that have both supervision, participants were asked what their preferred supervision is and most of them opted for a supervised HIVST than an unsupervised HIVST.^38,39 Supervised HIVST, also known as assisted HIVST, involves a trained provider who will assist the individual in the proper process of self-testing. Meanwhile, unsupervised HIVST or unassisted HIVST is when the individual does the self-test process alone and only involves manufacturer-provided instructions.^7,8

Willingness to pay

From the seven studies included in this parameter, one study conducted in Thailand reported that key informants (MSM, TGW) prefer getting tested if the testing kits are free³⁶ but also took the idea of paying if it ranges from 1 USD up to 10 USD⁴⁰ The acceptability of HIVST was seen to be higher if it is given for free rather than charging the patients.^27,38 Two studies concluded the average price that MSM and TGW were willing to pay was 500 PHP/300 Thai baht or approximately 9.30 USD^36,37 where the participants preferred low-priced and oral-based testing kits.³⁷ Most older men would rather choose the traditional testing method since the HIVST kits are only good for single-use and are needed for another confirmatory testing if the patient tested positive. Unlike younger generations who choose to seek information on the web, these said participants (older men) lack the access to know about HIVST, resulting in the hesitancy to buy testing kits.²⁵ MSM, PWID, and TGW from urban areas stated their likeness to paying 5.4 USD, followed by 4.3 USD and 3.9 USD as the lowest price limit.³² MSM key informants from low-income classes reported willingness to pay up to 200 PHP maximum (3.39 USD) unlike those from middle to high-income social classes including TGW are more likely to pay between 50 (0.85 USD) and 875 (14.83 USD) pesos.⁴⁰

Number of first-time testers

Seven studies were included in this parameter where the proportion of first-time testers is shown in Table 1.^{14,31,33,34,36,39,41} In a cross-sectional study from Thailand, MSM first-time testers were more likely to choose supervised HIVST than repeat testers whereas there was no significant difference found among TGW. In addition, TGW first-time testers were considerably more likely to get a reactive result in comparison with repeat testers. On the other hand, the difference between MSM first-time testers’ and repeat testers’ reactive results were not substantial.³⁶ In another cross-sectional study from Vietnam, MSM first-time testers seeking unsupervised HIVST were linked to a lower level of educational attainment, while MSM first-time testers choosing supervised HIVST were associated with being young, having lower income, and no sex traded for money.³⁹ Lastly, a cohort study from Thailand reported that the use of online, supervised HIVST can help engage a high proportion of TGW and MSM first-time testers as well as those with high prevalence of HIV.³⁴

Willingness to recommend the test

A cross-sectional study used a structured questionnaire to determine the participants' intention to use HIVST and whether they would recommend it to their social networks. Among the 391 MSM and TGW participants, 58.3% of MSM and 32.5% of TGW reported that they were extremely willing to recommend the testing modality to their friends.³⁶ In a different study, an electronic survey questionnaire was also used as part of the intervention. When asked whether they would recommend HIVST to their partner, friend, or a family member, the majority of the participants (98.5%) reported that they would.³¹ Another study that conducted a post-test acceptability survey, 63.3% of their participants stated that they would recommend HIVST to their partners.⁴²

HIVST usage of partners and friends

Among the included studies reported in this review, only one study examined this parameter. A qualitative study from the Philippines reported that MSM and TGW participants showed interest in partner testing. They perceived that the use of HIVST could result in a shift in relationship dynamics with an increased ability in making decisions regarding sexual intercourse. In addition, the TGW participants deemed that HIVST may help strengthen their relationships through increasing mutual trust.³⁸

Feasibility

HIVST was also found to be feasible among key populations due to the low occurrence of errors in conducting self-testing, interpretability of results,^31,36,40,41 and low percentage of invalid and false-reactive results.^{31,33,36,40,41}

Readability and error rate

Four studies examined readability and error rate and showed that a high percentage of participants (MSM and TGW) could interpret their results, whereas 1.6 to 3.1% had difficulty interpreting their results.^31,36,40,41 MSM and TGW who were unable to interpret their test results were among the unsupervised HIVST approach.³⁶ A cross-sectional study conducted in Thailand observed that there were fewer invalid tests in young MSM and TGW who were given instructions through a 4-minute video than in written instructions.⁴⁰ The same study examined the error rate where invalid results arose due to the participants’ varying levels of technical skills in conducting self-testing.⁴⁰ Similar studies examining feasibility of HIVST reported that errors were due to the incorrect usage of the buffer, incorrect time for reading the results,⁴³ and improper area of sample collection.⁴⁴ A cross-sectional study conducted in Singapore⁴⁴ reported that a false positive result may cause anxiety while a false negative result may cause continued high-risk behaviors for HIV transmission. Focus group discussions were conducted in two studies wherein the participants mentioned counseling as an integral part especially if the results of the test came out positive.^27,38

Diagnostic performance of HIVST

Five studies discussed the diagnostic performance of HIVST and showed consistency in results from HIVST to HIV confirmatory testing.^{31,33,36,40,41} Three included studies showed that most of their participants (MSM, TGW, FSW) preferred blood-based HIVST as they perceived it to be more accurate^27,31,38 and were more familiar with blood-based HIVST than with oral HIVST.²⁷ A cohort study in Vietnam observed that reactivity rate was higher in unsupervised than in supervised HIVST¹⁴ whereas a cross-sectional study in Thailand³⁶ showed otherwise. Reactive results were more likely observed in first-time testers than repeat testers.³⁶

Discussion

This scoping review is the first to systematically collect and summarize the available literature on the acceptability and feasibility of HIVST in Southeast Asia. HIVST was found to be acceptable and feasible among a wide variety of key populations. However, several issues must be addressed to optimize its use.

The costs of HIVST for individual use were one of the issues identified in this review. Key populations with low socio-economic status or who lived in rural, underserved areas were less likely to use the tests. Similarly, lower-middle-income groups would more likely get tested if HIVST was provided in community clinics for free. In contrast, middle to higher-middle-income groups reported being willing to pay for the testing kits. Compared with a scoping review conducted in sub-Saharan Africa, it was stated that the government should provide testing kits freely.²⁰ Others, however, are still open to purchasing kits in establishments that serve confidentiality and security.²⁰ The cost-effectiveness of the testing kit was also a concern for those living in geographically and socioeconomically disadvantaged areas despite its higher accessibility to patients in pharmacies.⁴⁵ Hence, conducting a cost-effectiveness evaluation of testing kits in Southeast Asia is suggested as disparities exist by income and geographic location, as in sub-Saharan Africa.

Home delivery³³ and community-based organization-delivered testing³⁹ were the preferred models for distribution of HIVST, specifically among MSM in this review. In sub-Saharan Africa, the preferred distribution of HIVST was through pharmacies by the general population, home delivery by young people, lodges and bars by men,⁴⁶ and peer-led distribution by adolescents.²⁵ This finding implies that the most suitable distribution points of the HIVST kits²⁰ must be considered to ensure that the intervention reaches the target population.

As per readability and error rate, this review found that unsupervised HIVST³⁶ and being a first-time tester are associated with misinterpretation of test results.³⁹ In a cross-sectional study conducted in the Democratic Republic of the Congo, a low level of education was associated with HIVST misinterpretation.²⁵ While MSM and TGW preferred supervised HIVST in this review, they were still hesitant to get tested in clinics due to fear of crossing paths with familiar faces.³⁴ Thus, to ensure reliable test results, it is essential to educate HIVST testers, particularly first-time users, by providing supporting materials for instruction and supervision from health workers. In addition, privacy in testing facilities may reduce their fear and provide them with a safe space for supervised HIVST.

This review found that Malaysia currently has no licensed or approved HIVST kit,^33,35 and HIVST is yet to be available in Myanmar.³¹ Currently, Malaysia and the Philippines do not have any formal regulation of HIVST kits; however, unregulated HIVST kits are available for purchase through the internet or online^33,35,38 and in pharmacies.³³ HIVST kits in Southeast Asia should be regulated and approved by the government to increase the uptake of HIVST effectively and ensure the users' safety. To regulate HIVST kits effectively and efficiently in the region, the national regulatory authorities may refer to WHO guidelines and tools, such as the global benchmarking tool, as these can help develop and strengthen regulatory systems for medical devices, including in-vitro diagnostics.¹⁰ Furthermore, adopting a stepwise approach is recommended in developing regulations and should include the following components: market authorization (registration), premarket controls, market control, post-market surveillance, and market surveillance/control. Market and post-market surveillance assure that the products are continuously in compliance with the national regulatory standards for safety, quality, and performance and aids in continuous product monitoring to identify and address possible complaints and adverse events, respectively.¹⁰ Thus, giving the users protection against counterfeit products and poor-quality tests.

The inclusion of HIVST is crucial in the region's HIV-elimination plans. The implementation of WHO HIV prevention and treatment guidance led to significant progress including the adoption of HIVST, to reach the first 90% of the UNAIDS 90-90-90 initiative by 2020.⁴⁷ In response to this implementation, HIVST policies have been incorporated in several Southeast Asian countries (Indonesia, Malaysia, Myanmar, Philippines, Singapore, Thailand, Cambodia, Laos, and Vietnam),¹⁰ whereas some countries in the region still do not have an HIVST policy (Brunei)¹⁵ and others remain unknown (Timor-Leste).¹⁶ Moreover, with the updated UNAIDS 95-95-95 targets by 2025, one of the suggested priority actions in the region is to integrate a fully operationalized HIVST and add it as a significant component of the national response.⁴⁷

This review found limited evidence on partner testing, willingness to recommend the test, and error rate of HIVST. A previous review conducted in low- and middle-income countries showed promising results of peer-based distribution.³ Concerning error rates, this review highlighted counseling as an integral part of HIVST, which aligns with previous studies.^{3,20,25,45,48–50} Tertiary students in sub-Saharan Africa have shown that their preferred pretest counseling was through instruction leaflets,⁴⁶ whereas in this review, it was conducted through a hotline and in an online assessment for older and younger MSM, respectively.²⁹ In another study in sub-Saharan Africa, the lack of physical consultations decreased the significance of HIVST. Despite the consideration of getting tested for HIV, participants still fear discrimination from strangers. This resulted in patients wanting to be counseled through phone calls than through face-to-face counseling.²⁰ This review suggests the potential of digital interventions such as telehealth in providing counseling for HIVST.

Overall, we found few local studies on the acceptability and feasibility of HIVST within Southeast Asia. Studies were limited to those written in the English language. Hence, studies written in other languages may have been overlooked. Regardless, we extensively searched the literature using eight electronic databases, gray literature, and hand-searched references of included studies. We did not limit the key population to a single gender or classification and included different sexual orientations. The use of different literature reviews to study the acceptability and feasibility of HIVST in Southeast Asia cannot represent the overall key populations in the region as the data collected from the included studies have different study designs, populations, and approaches used. The acceptability and feasibility outcomes were sometimes different across included studies. Hence, the study’s findings may not be true to other key populations around Southeast Asia and should not be applied to them accordingly.

Despite the wide range of data on the effectiveness of HIVST implementation, some gaps remain. There is a need to identify the key populations’ knowledge regarding HIVST to determine what policies will help in the promotion and awareness of HIVST in Southeast Asia. It is also essential to identify the factors that influence error rates and examine effective strategies to minimize the error rates related to conducting the test and interpreting its results. Additionally, given that the cost of test kits significantly affects key populations’ preferences, a cost-effectiveness type of study will help improve HIVST implementation. Future studies are warranted to explore and address these research gaps.

Conclusions

Evidence showed that HIVST was acceptable and feasible, which makes it a useful tool in increasing HIV testing coverage in Southeast Asia. Issues identified that should be considered in implementing HIVST include costs of HIVST for individual use, distribution mode, type of supervision for HIVST, and counseling. Despite the availability of HIVST, the geographic location and socioeconomic status significantly affect the acceptability and feasibility of HIVST among Southeast Asian countries. HIVST should be regulated and licensed in Southeast Asian countries to have better recognition as a supplement to HTS.

Supplemental Material

Supplemental Material - Acceptability and feasibility of HIV self-testing in Southeast Asia: A scoping review

Supplemental Material for Acceptability and feasibility of HIV self-testing in Southeast Asia: A scoping review by Joshel Mary Entierro, Kimberly Camañag, Kianna Marie Muyot, Mitzi Ingrid Rubio, Kevin Jace Miranda, and Rogie Royce Carandang in International Journal of STD & AIDS

Footnotes

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Joshel Mary Entierro

Supplemental Material

Supplemental material for this article is available online.

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