Home-based HIV testing and counselling (HTC) achieves high uptake, but is difficult and expensive to implement and sustain. We investigated a novel alternative based on HIV self-testing (HIVST). The aim was to evaluate the uptake of testing, accuracy, linkage into care, and health outcomes when highly convenient and flexible but supported access to HIVST kits was provided to a well-defined and closely monitored population. Following enumeration of 14 neighbourhoods in urban Blantyre, Malawi, trained resident volunteer-counsellors offered oral HIVST kits (OraQuick ADVANCE Rapid HIV-1/2 Antibody Test) to adult (≥16 y old) residents (n = 16,660) and reported community events, with all deaths investigated by verbal autopsy. Written and demonstrated instructions, pre- and post-test counselling, and facilitated HIV care assessment were provided, with a request to return kits and a self-completed questionnaire. Accuracy, residency, and a study-imposed requirement to limit HIVST to one test per year were monitored by home visits in a systematic quality assurance (QA) sample. Overall, 14,004 (crude uptake 83.8%, revised to 76.5% to account for population turnover) residents self-tested during months 1–12, with adolescents (16–19 y) most likely to test. 10,614/14,004 (75.8%) participants shared results with volunteer-counsellors. Of 1,257 (11.8%) HIV-positive participants, 26.0% were already on antiretroviral therapy, and 524 (linkage 56.3%) newly accessed care with a median CD4 count of 250 cells/μl (interquartile range 159–426). HIVST uptake in months 13–24 was more rapid (70.9% uptake by 6 mo), with fewer (7.3%, 95% CI 6.8%–7.8%) positive participants. Being “forced to test”, usually by a main partner, was reported by 2.9% (95% CI 2.6%–3.2%) of 10,017 questionnaire respondents in months 1–12, but satisfaction with HIVST (94.4%) remained high. No HIVST-related partner violence or suicides were reported. HIVST and repeat HTC results agreed in 1,639/1,649 systematically selected (1 in 20) QA participants (99.4%), giving a sensitivity of 93.6% (95% CI 88.2%–97.0%) and a specificity of 99.9% (95% CI 99.6%–100%). Key limitations included use of aggregate data to report uptake of HIVST and being unable to adjust for population turnover. Community-based HIVST achieved high coverage in two successive years and was safe, accurate, and acceptable. Proactive HIVST strategies, supported and monitored by communities, could substantially complement existing approaches to providing early HIV diagnosis and periodic repeat testing to adolescents and adults in high-HIV settings. Every year, about 2.1 million people (70% of whom live in sub-Saharan Africa) are newly infected with HIV, the virus that causes AIDS, and 1.5 million people (again, mainly in sub-Saharan Africa) die as a result. HIV, which is usually transmitted through unprotected sex with an infected individual, gradually destroys CD4 lymphocytes and other immune system cells, leaving HIV-positive individuals susceptible to other serious infections and to unusual cancers. HIV is diagnosed by looking for antibodies to HIV in blood or saliva. After diagnosis, the progression of HIV infection is monitored by regularly counting the number of CD4 cells in the blood. Initiation of antiretroviral therapy—a combination of drugs that keeps HIV replication in check but that does not cure the infection—is recommended when an individual’s CD4 count falls below 500 cells/μl or when he or she develops an AIDS-defining condition. HIV-positive individuals need to know their status so that they can take steps to avoid transmitting the virus to other people (for example, by always using a condom during sexual intercourse) and so that they can begin treatment. Treatment helps to keep HIV-positive individuals healthy but also reduces their chances of transmitting the virus to their sexual partners. Unfortunately, many HIV-positive individuals are unaware of their status. The situation is particularly bad in sub-Saharan Africa, where, despite major investments in facility-based and community-based HIV testing and counseling (HTC) programs, only a quarter of adults have had a recent HIV test, and only half of the people living with HIV know they are HIV positive. Barriers to facility-based HTC include concern about lack of confidentiality and fears of stigmatization. Home-based HTC avoids some of these barriers and can achieve high uptake of testing, but doubts have been expressed about the sustainability of this approach to testing. Here, the researchers evaluate an alternative to home-based HTC—HIV self-testing (HIVST)—by undertaking a community-based prospective study of HIVST in Blantyre, Malawi. HIVST involves individuals performing and interpreting their own HIV test and has the potential to be widely implemented with minimal involvement of trained healthcare workers. Trained resident volunteer-counselors offered one oral HIVST kit (a kit that measures HIV in saliva) per year for a two-year period to 16,660 adult residents in 14 neighborhoods in urban Blantyre. All the participants received instructions on how to use the kits, pre- and post-counseling, and, for participants self-testing HIV positive, a referral card to attend an HIV care clinic. The residents also completed a questionnaire about their experience of HIVST. Three-quarters of the residents self-tested in the first and second year of the study. HIVST uptake was more rapid in the second year than in the first year and was high among men and adolescents, two hard-to-reach populations. Three-quarters of the residents who self-tested during the first year of the study shared their results with a volunteer-counselor. Of the 1,257 participants who discovered they were HIV positive during the first year of the study, more than half accessed HIV care. Importantly, 94.4% of the participants reported that they were happy with HIVST even though 2.9% reported being forced to take the test, usually by a main partner; no HIVST-related partner violence or suicides were reported by the study’s community surveillance system. Finally, HIVST and repeat HTC results agreed in 99.4% of participants selected as a quality assurance sample (one in 20 of the participants). These findings show that, in urban neighborhoods in Malawi, coverage with community-based HIVST was high (particularly among adolescents and men) in two successive years and that HIVST was safe, accurate, and acceptable. Importantly, HIVST using a delivery model based on trained volunteers led to acceptable linkage into HIV care services, and the approach had a very low incidence of major social harms such as partner violence. Uncertainty about estimates of uptake and linkage to care and other aspects of the study design may limit the accuracy of these results. Nevertheless, these findings suggest that scaling up HIVST could complement existing strategies for providing early HIV diagnosis and periodic repeat testing and could thus have a sustained impact on the coverage of HIV testing and care in Africa and on the control of the HIV/AIDS epidemic. This list of resources contains links that can be accessed when viewing the PDF on a device or via the online version of the article at http://dx.doi.org/10.1371/journal.pmed.1001873.

Although HIV testing and counseling (HTC) uptake has increased dramatically in Africa, facility-based services are unlikely to ever meet ongoing need to the full. A major constraint in scaling up community and home-based HTC services is the unacceptability of receiving HTC from a provider known personally to prospective clients. We investigated the potential of supervised oral HIV self-testing from this perspective. Adult members of 60 households and 72 members of community peer groups in urban Blantyre, Malawi, were selected using population-weighted random cluster sampling. Participants were offered self-testing plus confirmatory HTC (parallel testing with two rapid finger-prick blood tests), standard HTC alone, or no testing. 283 (95.6%) of 298 selected adults participated, including 136 (48.0%) men. 175 (61.8%) had previously tested (19 known HIV positive), although only 64 (21.5%) within the last year. HIV prevalence was 18.5%. Among 260 (91.9%) who opted to self-test after brief demonstration and illustrated instructions, accuracy was 99.2% (two false negatives). Although 98.5% rated the test “not hard at all to do,” 10.0% made minor procedural errors, and 10.0% required extra help. Most participants indicated willingness to accept self-test kits, but not HTC, from a neighbor (acceptability 94.5% versus 46.8%, p = 0.001). Oral supervised self-testing was highly acceptable and accurate, although minor errors and need for supervisory support were common. This novel option has potential for high uptake at local community level if it can be supervised and safely linked to counseling and care. Please see later in the article for the Editors' Summary

In 2012, an estimated 35 million individuals were infected with the human immunodeficiency virus (HIV).¹ Antiretroviral therapy (ART) substantially reduces the risk of onward HIV transmission as well as greatly reducing morbidity and mortality,^2,3 raising hopes that high uptake of annual HIV testing and early initiation of ART could improve HIV prevention as well as care.^4,5

Introduction: In the era of ambitious HIV targets, novel HIV testing models are required for hard‐to‐reach groups such as men, who remain underserved by existing services. Pregnancy presents a unique opportunity for partners to test for HIV, as many pregnant women will attend antenatal care (ANC). We describe the views of pregnant women and their male partners on HIV self‐test kits that are woman‐delivered, alone or with an additional intervention.Methods: A formative qualitative study to inform the design of a multi‐arm multi‐stage cluster‐randomized trial, comprised of six focus group discussions and 20 in‐depth interviews, was conducted. ANC attendees were purposively sampled on the day of initial clinic visit, while men were recruited after obtaining their contact information from their female partners. Data were analysed using content analysis, and our interpretation is hypothetical as participants were not offered self‐test kits.Results: Providing HIV self‐test kits to pregnant women to deliver to their male partners was highly acceptable to both women and men. Men preferred this approach compared with standard facility‐based testing, as self‐testing fits into their lifestyles which were characterized by extreme day‐to‐day economic pressures, including the need to raise money for food for their household daily. Men and women emphasized the need for careful communication before and after collection of the self‐test kits in order to minimize the potential for intimate partner violence although physical violence was perceived as less likely to occur. Most men stated a preference to first self‐test alone, followed by testing as a couple. Regarding interventions for optimizing linkage following self‐testing, both men and women felt that a fixed financial incentive of approximately USD$2 would increase linkage. However, there were concerns that financial incentives of greater value may lead to multiple pregnancies and lack of child spacing. In this low‐income setting, a lottery incentive was considered overly disappointing for those who receive nothing. Phone call reminders were preferred to short messaging service.Conclusions: Woman‐delivered HIV self‐testing through ANC was acceptable to pregnant women and their male partners. Feedback on additional linkage enablers will be used to alter pre‐planned trial arms.

Men’s healthcare-seeking delay results in higher mortality while on HIV or tuberculosis (TB) treatment, and implies contribution to ongoing community-level TB transmission before initiating treatment. We investigated masculinity’s role in healthcare-seeking delay for men with TB-suggestive symptoms, with a view to developing potential interventions for men. Data were collected during March 2011- March 2012 in three high-density suburbs in urban Blantyre. Ten focus group discussions were carried out of which eight (mixed sex = two; female only = three; male only = three) were with 74 ordinary community members, and two (both mixed sex) were with 20 health workers. Individual interviews were done with 20 TB patients (female =14) and 20 un-investigated chronic coughers (female = eight), and a three-day workshop was held with 27 health stakeholder representatives. An expectation to provide for and lead their families, and to control various aspects of their lives while facing limited employment opportunities and small incomes leaves men feeling inadequate, devoid of control, and anxious about being marginalised as men. Men were fearful about being looked at as less than men, and about their wives engaging in extramarital sex without ability to detect or monitor them. Control was a key defining feature of adequate manhood, and efforts to achieve it also led men into side-lining their health. Articulate and consistent concepts of men’s bodily strength or appropriate illness responses were absent from the accounts. Facilitating men to seek care early is an urgent public health imperative, given the contexts of high HIV/AIDS prevalence but increasingly available treatment, and the role of care-seeking delay in TB transmission. Men’s struggles trying to achieve ideal images seem to influence their engagement with their health. Ambiguous views regarding some key masculinity representations and the embrace of less harmful masculinities raise questions about some common assumptions that guide work with men. Apparent ‘emergent masculinities’ might be a useful platform from which to support the transformation of harmful masculinity. Finally, the complex manifestations of masculinity indicate the need for interventions targeting men in health and TB control to assume supportive, multidimensional and long-term outlooks.

Background: In Southern Malawi, the fishing industry is highly gendered, with men carrying out the fishing and women processing, drying and selling the fish. Research has shown that individuals living in fishing communities in low‐income countries are particularly vulnerable to HIV infection. One of the key drivers of HIV in fishing communities is transactional sex. In the fishing industry this takes the form of “fish‐for‐sex” networks where female fish traders exchange sex with fishermen for access to or more favourable prices of fish. By controlling the means of production, the power dynamics in these exchanges favour men and can make it more difficult for women to negotiate safe sex.Methods: Qualitative methods were used to collect data on gendered drivers of transactional sex in the fishing community and how different groups perceive HIV risk in these transactions. Observation, focus group discussions and semi‐structured interviews were undertaken with members of the fishing communities, including men and women directly and indirectly involved in fishing.Results: In fishing communities transactional sex was prevalent across a spectrum ranging from gift giving within relationships, to sex for fish exchanges, to sex worker encounters. Power differences between couples in transactional sexual encounters shape individual’s abilities to negotiate condom use (with women being at a particularly disadvantaged negotiating position). The context and motivations for transactional sex varied and was mediated by economic need and social position both of men and women. Female fish traders new to the industry and boat crew members who travelled for work and experienced difficult living conditions often engaged in transactional sex.Conclusions: Transactional sex is common in Malawian fishing communities, with women particularly vulnerable in negotiations because of existing gendered power structures. Although knowledge and understanding of the HIV risk associated with transactional sex was common, this did not appear to result in the adoption of risk reduction strategies. This suggests that specially targeted strategies to increase women’s economic empowerment and tackle the structural drivers of women’s HIV risk could be important in fishing communities.