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HIV self-testing (HIVST) has the potential to increase uptake of HIV testing among untested populations in sub-Saharan Africa and is on the brink of scale-up. However, it is unclear to what extent HIVST would be supported by stakeholders, what policy frameworks are in place and how variations between contexts might influence country-preparedness for scale-up. This qualitative study assessed the perceptions of HIVST among stakeholders in three sub-Saharan countries. Fifty-four key informant interviews were conducted in Kenya (n=16), Malawi (n=26) and South Africa (n=12) with government policy makers, academics, activists, donors, procurement specialists, laboratory practitioners and health providers. A thematic analysis was conducted in each country and a common coding framework allowed for inter-country analysis to identify common and divergent themes across contexts. Respondents welcomed the idea of an accurate, easy-to-use, rapid HIV self-test which could increase testing across all populations. High-risk groups, such as men, Men who have sex with men (MSM), couples and young people in particular, could be targeted through a range of health facility and community-based distribution points. HIVST is already endorsed in Kenya, and political support for scale-up exists in South Africa and Malawi. However, several caveats remain. Further research, policy and ensuing guidelines should consider how to regulate, market and distribute HIVST, ensure quality assurance of tests and human rights, and critically, link testing to appropriate support and treatment services. Low literacy levels in some target groups would also need context-specific consideration before scale up. World Health Organization (WHO) policy and regulatory frameworks are needed to guide the process in those areas which are new or specific to self-testing. Stakeholders in three HIV endemic sub-Saharan countries felt that HIVST will be an important complement to existing community and facility-based testing approaches if accompanied by the same essential components of any HIV testing service, including access to accurate information and linkages to care. While there is an increasingly positive global policy environment regarding HIVST, several implementation and social challenges limit scale-up. There is a need for further research to provide contextual and operational evidence that addresses concerns and contributes to normative WHO guidance.
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... Despite the existing WHO HIVST guidelines and technical recommendations that highlight the potential contribution of HIVST to close gaps in universal HIV testing coverage, most SSA countries, including Tanzania, have lagged in the adoption of HIVST [46,47]. HIV policymakers, experts, and government stakeholders in many African countries have expressed several concerns, challenges, and criticism related to HIVST [36,48]. The main concerns against HIVST include potential psychological and social harm due to lack of face-to-face counseling, risks of inaccurate results, and uncertainty over linkage to care for individuals with a reactive HIVST test result [36,[48][49][50]. ...
... HIV policymakers, experts, and government stakeholders in many African countries have expressed several concerns, challenges, and criticism related to HIVST [36,48]. The main concerns against HIVST include potential psychological and social harm due to lack of face-to-face counseling, risks of inaccurate results, and uncertainty over linkage to care for individuals with a reactive HIVST test result [36,[48][49][50]. Since HIVST is a new modality, some of the concerns about HIVST, such as the potential for psychological and social harm, are not found in evidence [50]. ...
... What are the HIVST practices after receiving the kit? Some studies examining perception related to the introduction of HIVST among stakeholders in Africa generally casts doubt on the effective use of the distributed kits, the capacity of key populations to use HIVST and correctly interpret the results [5,[19][20][21][22], and the ability of those populations to access care services [21][22][23]. ...
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Introduction HIV epidemics in Western and Central Africa (WCA) remain concentrated among key populations, who are often unaware of their status. HIV self-testing (HIVST) and its secondary distribution among key populations, and their partners and relatives, could reduce gaps in diagnosis coverage. We aimed to document and understand secondary HIVST distribution practices by men who have sex with men (MSM), female sex workers (FSW), people who use drugs (PWUD); and the use of HIVST by their networks in Côte d’Ivoire, Mali, and Senegal. Methods A qualitative study was conducted in 2021 involving (a) face-to-face interviews with MSM, FSW, and PWUD who received HIVST kits from peer educators (primary users) and (b) telephone interviews with people who received kits from primary contacts (secondary users). These individual interviews were audio-recorded, transcribed, and coded using Dedoose software. Thematic analysis was performed. Results A total of 89 participants, including 65 primary users and 24 secondary users were interviewed. Results showed that HIVST were effectively redistributed through peers and key populations networks. The main reported motivations for HIVST distribution included allowing others to access testing and protecting oneself by verifying the status of partners/clients. The main barrier to distribution was the fear of sexual partners’ reactions. Findings suggest that members of key populations raised awareness of HIVST and referred those in need of HIVST to peer educators. One FSW reported physical abuse. Secondary users generally completed HIVST within two days of receiving the kit. The test was used half the times in the physical presence of another person, partly for psychological support need. Users who reported a reactive test sought confirmatory testing and were linked to care. Some participants mentioned difficulties in collecting the biological sample (2 participants) and interpreting the result (4 participants). Conclusion The redistribution of HIVST was common among key populations, with minor negative attitudes. Users encountered few difficulties using the kits. Reactive test cases were generally confirmed. These secondary distribution practices support the deployment of HIVST to key populations, their partners, and other relatives. In similar WCA countries, members of key populations can assist in the distribution of HIVST, contributing to closing HIV diagnosis gaps.
... Multi-country evidence confirms the high acceptability, feasibility, and accuracy of HIVST across populations with minimal harm [1,[4][5][6][7][8][9][10][11][12][13]. HIVST is highly acceptable due to its convenience, privacy, confidentiality, and ease of use [14][15][16]. Although studies report oral fluidbased HIVST was preferred because of its ease of use and it being noninvasive and painless [17][18][19][20][21][22][23], little is known about blood-based HIVST. ...
... Many barriers prevent the adoption and scale-up of HIVST in LMICs, including concerns over accuracy, feasibility, acceptability, and cost of HIVST [15,25,26,44]. WHO recommended that all HIV testing algorithms achieve at least 99% positive predictive value and use a combination of tests with at least 99% sensitivity and 98% specificity to maintain the accuracy and reliability of HIV diagnosis [1]. ...
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HIV self-testing (HIVST) is an effective approach to increase testing uptake. While oral fluid-based HIVST has been rapidly scaled, use of blood-based HIVST remains limited. We evaluated the acceptability, feasibility, and accuracy of blood-based HIVST among lay users in Ho Chi Minh City (HCMC), Vietnam. We conducted a cross-sectional study among HIV testing clients at the HCMC Pasteur Institute from March 2019 to October 2020. Participants received one HIVST kit and performed the test in front of an observer. The observer used product-specific questionnaires to collect information on the HIVST process, test results, experiences. The participants’ interpretations of HIVST results were compared to health staff’s interpretations and gold standard laboratory EIA reference tests. Of 2,399 participants who accepted HIVST, 64.7% were men, 62.1% aged 25–49 years, 53.5% had a higher education level, 41.4% were employed, and 35.6% were first-time testers. The vast majority (94.4%) desired to use the test in the future, and 93.9% reported willingness to recommend the test. The majority (90.8%) of participants successfully completed the self-test. One factor associated with successful completion was higher education level (aOR = 1.85; 95% CI: 1.32–2.61); while participants self-testing with SURE CHECK (aOR = 0.21; 95% CI: 0.12–0.37), INSTI (aOR = 0.23; 95% CI: 0.13–0.39), and BioSURE (aOR = 0.29; 95% CI: 0.17–0.51) or being unemployed, retired, or doing housework (aOR = 0.45; 95% CI: 0.25–0.82) were less likely to perform the test successfully. Agreement of positive and negative HIVST results as interpreted by participants and health staff was high (98.1% and 99.9%, respectively). Sensitivity and specificity of the evaluated HIVST were 96.43% (95% CI: 93.62–99.23) and 99.9% (95% CI: 99.75–100), respectively. Our findings confirm that blood-based HIVST is highly acceptable, feasible, and accurate. This evidence informs scale-up of HIVST to increase uptake of essential HIV prevention and treatment services.
... Our study has revealed that factors hampering the market growth from the supply side dynamics includes forecasting, point of care service delivery, dominance of free and socially marketed HIVST on the market, neglected private sector in the public health system, limited demand for HIVST among key populations and the general population at large, and regulatory bottlenecks influencing the overall market dynamics. This finding, supported by previous research through the Self-Testing Africa (STAR) initiative project [19,20], highlights the critical challenges faced in the HIVST sustainable market implementation, positive policy environment and social challenges limiting scale-up and acceleration of market development work. ...
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Background The continuous supply of affordable and quality HIV self-test (HIVST) is a key pillar toward achieving the global HIV 95–95-95 target in Nigeria. This was a descriptive qualitative study that explored private sector stakeholders’ perceptions of the enablers and barriers of the HIVST market in Nigeria. Methods A total of 29 In-depth interviews (IDIs) were conducted with HIVST supply chain stakeholders and private sector providers (PPMVs and Community Pharmacies). Responses were analyzed using Nvivo software and we systematically developed a total market approach analysis for supply chain stakeholders and archetypes for community Pharmacies and PPMVs based on insights gathered from their journey map. Results Challenges to the supply side dynamics include forecasting, point of care service delivery, the availability of free and subsidized HIVST kits in the market, neglect of private sector providers (Community Pharmacists and PPMVs) in the healthcare delivery system, limited demand for HIVST, and regulatory bottlenecks influences the overall market dynamics. High cost of the HIVST kit, which triggers low availability, accessibility and affordability from the demand side, depicts the need to understand the market dynamics. Addressing the barriers and optimizing the enablers of the three-model pharmacist and PPMV’s will change the market dynamic and service delivery to generate demand. Conclusion To address challenges which already exist, the government need to revise the process guidelines for introducing new HIVST products in the Nigerian market, developing contingency plans to ensure the supply of HIVST remains sufficient when experiencing economic shocks, and create a sustainable roadmap toward optimizing the market for HIVST kits.
Article
Background HIV testing rates among South African men lag behind rates for women and national targets. Community-based HIV self-screening (HIVSS) distribution and follow-up by community health workers (CHWs) is a scalable option to increase testing coverage, diagnosis, and treatment initiation. We provided HIVSS and assisted linkage to care to men not recently tested (within past 12 months) residing in high-HIV-burden areas of Johannesburg. Methods CHWs distributed HIVSS in six clinic catchment areas. Follow-up to encourage confirmatory testing and ART initiation was conducted through personal support (PS) or an automated SMS follow-up and linkage system in three clinic areas each. Using a quasi-experimental pre-post design, we compared differences in the proportion of men testing in the clinic catchment areas during the HIVSS campaign (June-Aug 2019) to the three months prior (March-May 2019) and compared treatment initiations by assisted linkage strategy. Results Among 4,793 participants accepting HIVSS, 62% had never tested. Among 3,993 participants with follow-up data, 90.6% reported using their HIVSS kit. Testing coverage among men increased 156%, from under 4% when only clinic-based HIV testing services (HTS) were available to 9.5% when HIVSS and HTS were available (z=-11.6; p<0.01). Reported test use was higher for men followed through PS (99% vs 68% in SMS); however, significantly more men reported reactive self-test results in the SMS group compared to PS (6.4% vs 2.0%), resulting in more ART initiations in the SMS group compared to PS (23 vs 9; p<0.01). Conclusion CHW HIVSS distribution significantly increases testing among men. While PS enabled personalized follow-up, reporting differences indicate SMS is more acceptable and better aligned with expectations of privacy associated with HIVSS.
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Objectives Although HIV self-testing technologies have created new opportunities for achieving national and global HIV testing goals, current developments have not been compiled to inform policy and practice, especially in high HIV burden countries of Africa. We aimed to compile and synthesize the evidence about HIV self-testing technologies, strategies, and uptake in the top-10 high HIV burden countries of Africa. Methods We searched CINAHL, PubMed, Web of Science, PsycINFO, Social Science Citation Index, and EMBASE to include eligible articles published in English between January 2012 and November 2022. Results In total, 865 articles were retrieved and only 16 studies conducted in five African countries were eligible and included in this review. The two types of HIV self-testing modalities presently being used in Africa are: The first is Home Self-Test which is done entirely at home or in another private location by using oral fluid or blood specimen. The second modality is Mail-In Self-Test (self-sampling), where the user collects their own sample and sends this to a laboratory for testing. Perceived opportunities for the uptake of HIV self-testing were autonomy and self-empowerment, privacy, suitability, creating a chance to test, and simplicity of use. The potential barriers to HIV self-testing included fear and worry of a positive test result, concern of the test results is not reliable, low literacy, and potential psychological and social harms. The oral-fluid self-testing is preferred by most users because it is easy to use, less invasive, and painless. The difficulty of instructions on how to use self-test kits, and the presence of different products of HIV self-testing kits, increase rates of user errors. Conclusion Adopting HIV self-testing by overcoming the challenging potential barriers could enable early detection, care, treatment, and prevention of the disease to achieve the 95-95-95 goal by 2030. Further study is necessary to explore the actual practices related to HIV self-testing among different populations in Africa.
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Introduction Self-collected samples (SCS) for sexually transmitted infection (STI) testing have been shown to be feasible and acceptable in high-resource settings. However, few studies have assessed the acceptability of SCS for STI testing in a general population in low-resource settings. This study explored the acceptability of SCS among adults in south-central Uganda. Methods Nested within the Rakai Community Cohort Study, we conducted semistructured interviews with 36 adults who SCS for STI testing. We analysed the data using an adapted version of the Framework Method. Results Overall, SCS was acceptable to both male and female participants, regardless of whether they reported recent STI symptoms. Perceived advantages of SCS over provider-collection included increased privacy and confidentiality, gentleness and efficiency. Disadvantages included the lack of provider involvement, fear of self-harm and the perception that SCS was unhygienic. Most participants preferred provider-collected samples to SCS. Nevertheless, almost all said they would recommend SCS and would do it again in the future. Conclusion SCS are acceptable among adults in this low-resource setting and could be offered as an additional option to expand STI diagnostic services.
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Objectives Secondary distribution of HIV self-test (HIVST) kits from pregnant women attending antenatal care (ANC) to their male partners is shown to increase HIV couples testing and disclosure, and is being scaled up in sub-Saharan Africa. Understanding couples-level barriers and facilitators influencing HIVST uptake is critical to designing strategies to optimise intervention coverage. Design To investigate these couples-level barriers and facilitiators, we conducted focus group discussions and in-depth interviews. Transcripts were analysed thematically and the interdependence model of communal coping and health behaviour change was adapted to explore factors impacting HIVST acceptability. Setting We recruited pregnant women attending two public ANC clinics in Kampala, Uganda, and male partners of pregnant women between April 2019 and February 2020. Participants We conducted gender-stratified focus group discussions (N=14) and in-depth interviews (N=10) with pregnant women with and without HIV attending ANC, and male partners of pregnant women (N=122 participants). Intervention We evaluated pregnant women’s and male partners’ perceptions of HIVST secondary distribution in Uganda, leveraging the interdependence model of communal coping and health behaviour change. Primary and secondary outcome measures Key areas of focus included HIVST interest and acceptability, perspectives on HIV status disclosure to partners and gender roles. Results Participants felt that predisposing factors, including trust, communication, fear of partner and infidelity, would influence women’s decisions to deliver HIVST kits to partners, and subsequent communal coping behaviours such as couples HIV testing and disclosure. Pregnancy was described as a critical motivator for men’s HIVST uptake, while HIV status of pregnant women was influential in couples’ communal coping and health-enhancing behaviours. Generally, participants felt HIV-negative women would be more likely to deliver HIVST, while women with HIV would be more hesitant due to concerns about discovery of serodifference and relationship dissolution. Participants stressed the importance of counsellor availability throughout the process including guidance on how women should approach their partners regarding HIVST and post-test support in case of a positive test. Conclusions HIV-negative women in relationships with positive predisposing factors may be most likely to deliver HIVST and leverage interdependent coping behaviours. Women with HIV or those in relationships with negative predisposing factors may benefit from targeted counselling and disclosure support before and after HIVST kit distribution. Results can help support policy guidelines for HIVST kit distribution.
Article
Innovative diagnostic solutions are essential to improve COVID-19 case detection and slow its spread in resource-constrained settings. To understand how South African communities may utilise rapid SARS-CoV-2 antigen self-testing and react to self-test results, we conducted a qualitative study, involving semi-structured interviews and focus group discussions, of healthcare workers, representatives of civil society groups, and potential self-testing implementors. A sex- and location-sensitive thematic analysis approach was used to assess how 52 decision-takers on self-testing roll-out in South Africa perceive the value and utility of this innovative diagnostic approach. Informants suggested South Africans might value a device that allows them to self-test in private, at their own convenience, while avoiding the risk of social stigma and having to wait for COVID-19 test results in a facility. They also emphasised the need for awareness and sensitisation campaigns and to ensure pre-/post-self-test counselling services are easily accessible. Collaboration with traditional leaders and community-based organisations would improve results communication and linkage to counselling and confirmatory testing. SARS-CoV-2 self-testing was perceived to be acceptable to a population already sensitised to the use of HIV self-testing, being a decentralised solution that would help reduce the incidence of COVID-19 and prevent any further deterioration of socio-economic indicators.
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Introduction: in Nigeria, it was estimated that 1.9 million people were living with HIV of which 130,000 people were newly infected with HIV. HIV self-testing would potentially increase access to HIV testing for people to know their status, get diagnosed, and initiate treatment as soon as possible. Our study aims to assess the knowledge of HIV Self-Testing (HIVST) and the acceptability of this youth-friendly approach among students in southwest Nigeria online. Methods: a cross-sectional study was conducted among bona fide undergraduate students (2019/2020 session) of two popular tertiary institutions in southwest Nigeria. An online standardized self-administered questionnaire was administered using Google Forms. Microsoft Excel and IBM SPSS statistics were used for tabulation and statistical data analysis. The Chi-Square test was conducted using a P value of 0.05 to determine the level of significance. Results: of the 155 students that participated in the study, 82 (52.9%) were male. Most of the respondents (65.2%) were studying medicine and other health-related courses. The mean knowledge of HIVST among respondents was slightly above average. Respondents studying medical and other health-related courses showed a slightly better level of knowledge than others although not statistically significant (P = 0.222). 76.1% of respondents had never used the HIVST option before and 62.6% are willing to use it sometimes in the future. Conclusion: to achieve the UNAIDS 95-95-95 fast-track targets in Nigeria by 2030, there is a need to promote sexual and reproductive health education and increase awareness and accessibility of HIVST to youths.
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In a South African context, we consider the implications of the United States Food and Drug Administration’s recent approval of the OraQuick HIV self-testing kit. We argue that current law and policy inhibit the roll-out of accurate and well-regulated self-testing kits, and create a loophole for sale in supermarkets, but not pharmacies.
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In a South African context, we consider the implications of the United States Food and Drug Administration’s recent approval of the OraQuick HIV self-testing kit. We argue that current law and policy inhibit the roll-out of accurate and well-regulated self-testing kits, and create a loophole for sale in supermarkets, but not pharmacies.
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Approximately 60% of human immunodeficiency virus (HIV)-infected individuals are unaware of their infection, and stigma and discrimination continue to threaten acceptance of HIV testing services worldwide. Self-testing for HIV has garnered controversy for years and the debate reignited with the approval of a point-of-care test for over-the-counter sale in the US in 2012. Here, we present arguments for and against HIV self-testing. The case in support of HIV self-testing contends that: the modality is highly acceptable, especially among the most at-risk individuals; self-testing empowers users, thus helping to normalize testing; and mutual partner testing has the potential to increase awareness of risk and avert condomless sex between discordant partners. Arguments against HIV self-testing include: cost limits access to those who need testing most; false-negative results, especially during the window period, may lead to false reassurance and could promote sex between discordant partners at the time of highest infectivity; opportunities for counseling, linkage to care, and diagnosis of other sexually transmitted infections may be missed; and self-testing leads to potential for coercion between partners. Research is needed to better define the risks of self-testing, especially as performance of the assays improves, and to delineate the benefits of programs designed to improve access to self-test kits, because this testing modality has numerous potential advantages and drawbacks.
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Importance Self-testing for HIV infection may contribute to early diagnosis of HIV, but without necessarily increasing antiretroviral therapy (ART) initiation.Objective To investigate whether offering optional home initiation of HIV care after HIV self-testing might increase demand for ART initiation, compared with HIV self-testing accompanied by facility-based services only.Design, Setting, and Participants Cluster randomized trial conducted in Blantyre, Malawi, between January 30 and November 5, 2012, using restricted 1:1 randomization of 14 community health worker catchment areas. Participants were all adult (≥16 years) residents (n = 16 660) who received access to home HIV self-testing through resident volunteers. This was a second-stage randomization of clusters allocated to the HIV self-testing group of a parent trial.Interventions Clusters were randomly allocated to facility-based care or optional home initiation of HIV care (including 2 weeks of ART if eligible) for participants reporting positive HIV self-test results.Main Outcomes and Measures The preplanned primary outcome compared between groups the proportion of all adult residents who initiated ART within the first 6 months of HIV self-testing availability. Secondary outcomes were uptake of HIV self-testing, reporting of positive HIV self-test results, and rates of loss from ART at 6 months.Results A significantly greater proportion of adults in the home group initiated ART (181/8194, 2.2%) compared with the facility group (63/8466, 0.7%; risk ratio [RR], 2.94, 95% CI, 2.10-4.12; P < .001). Uptake of HIV self-testing was high in both the home (5287/8194, 64.9%) and facility groups (4433/8466, 52.7%; RR, 1.23; 95% CI, 0.96-1.58; P = .10). Significantly more adults reported positive HIV self-test results in the home group (490/8194 [6.0%] vs the facility group, 278/8466 [3.3%]; RR, 1.86; 95% CI, 1.16-2.97; P = .006). After 6 months, 52 of 181 ART initiators (28.7%) and 15 of 63 ART initiators (23.8%) in the home and facility groups, respectively, were lost from ART (adjusted incidence rate ratio, 1.18; 95% CI, 0.62-2.25, P = .57).Conclusions and Relevance Among Malawian adults offered HIV self-testing, optional home initiation of care compared with standard HIV care resulted in a significant increase in the proportion of adults initiating ART.Trial Registration clinicaltrials.gov Identifier: NCT01414413
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Although HIV self-testing may overcome some barriers to HIV testing, various stakeholders have expressed concerns that HIV self-testing may lead to unintended harm, including psychological, social and medical harm. Recognizing that similar concerns were raised in the past for some other self-tests, we conduct a review of the literature on a set of self-tests that share some characteristics with HIV self-tests to determine whether there is any evidence of harm. We find that although the potential for harm is discussed in the literature on self-tests, there is very little evidence that such harm occurs.
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Antiretroviral therapy (ART) significantly decreases HIV-associated morbidity, mortality, and HIV transmission through HIV viral load suppression. In high HIV prevalence settings, outreach strategies are needed to find asymptomatic HIV positive persons, link them to HIV care and ART, and achieve viral suppression. We conducted a prospective intervention study in two rural communities in KwaZulu-Natal, South Africa, and Mbabara district, Uganda. The intervention included home HIV testing and counseling (HTC), point-of-care CD4 count testing for HIV positive persons, referral to care, and one month then quarterly lay counselor follow-up visits. The outcomes at 12 months were linkage to care, and ART initiation and viral suppression among HIV positive persons eligible for ART (CD4≤350 cells/μL). 3,393 adults were tested for HIV (96% coverage), of whom 635 (19%) were HIV positive. At baseline, 36% of HIV positive persons were newly identified (64% were previously known to be HIV positive) and 40% were taking ART. By month 12, 619 (97%) of HIV positive persons visited an HIV clinic, and of 123 ART eligible participants, 94 (76%) initiated ART by 12 months. Of the 77 participants on ART by month 9, 59 (77%) achieved viral suppression by month 12. Among all HIV positive persons, the proportion with viral suppression (<1,000 copies/mL) increased from 50% to 65% (p=<0.001) at 12 months. Community-based HTC in rural South Africa and Uganda achieved high testing coverage and linkage to care. Among those eligible for ART, a high proportion initiated ART and achieved viral suppression, indicating high adherence. Implementation of this HTC approach by existing community health workers in Africa should be evaluated to determine effectiveness and costs.