Heidi van Rooyen

Project Accept (HPTN 043): a community-based intervention to reduce HIV incidence in populations at risk for HIV in sub-Saharan Africa and Thailand.

Background:Changing community norms to increase awareness of HIV status and reduce HIV-related stigma has the potential to reduce the incidence of HIV-1 infection in the developing world. Methods:We developed and implemented a multilevel intervention providing community-based HIV mobile voluntary counseling and testing, community mobilization, and posttest support services. Forty-eight communities in Tanzania, Zimbabwe, South Africa, and Thailand were randomized to receive the intervention or clinic-based standard voluntary counseling and testing (VCT), the comparison condition. We monitored utilization of community-based HIV mobile voluntary counseling and testing and clinic-based standard VCT by community of residence at 3 sites, which was used to assess differential uptake. We also developed quality assurance procedures to evaluate staff fidelity to the intervention. Findings:In the first year of the study, a 4-fold increase in testing was observed in the intervention versus comparison communities. We also found an overall 95% adherence to intervention components. Study outcomes, including prevalence of recent HIV infection and community-level HIV stigma, will be assessed after 3 years of intervention. Conclusions:The provision of mobile services, combined with appropriate support activities, may have significant effects on utilization of voluntary counseling and testing. These findings also provide early support for community mobilization as a strategy for increasing testing rates.

Universal HIV testing of infants at immunization clinics: an acceptable and feasible approach for early infant diagnosis in high HIV prevalence settings.

Objective:To determine the acceptability and feasibility of universal HIV testing of 6-week-old infants attending immunization clinics to achieve early diagnosis of HIV and referral for HIV treatment and care services. Design:An observational cohort with intervention. Methods:Routine HIV testing of infants was offered to all mothers bringing infants for immunizations at three clinics in KwaZulu Natal. Blood samples were collected by heel prick onto filter paper. Dried blood spots were tested for HIV antibodies and, if present, were tested for HIV DNA by PCR. Exit interviews were requested of all mothers irrespective of whether they had agreed to infant testing or not. Results:Of 646 mothers bringing infants for immunizations, 584 (90.4%) agreed to HIV testing of their infant and 332 (56.8%) subsequently returned for results. Three hundred and thirty-two of 646 (51.4%) mothers and infants thereby had their HIV status confirmed or reaffirmed by the time the infant was 3 months of age. Overall, 247 of 584 (42.3%) infant dried blood spot samples had HIV antibodies indicating maternal HIV status. Of these, 54 (21.9%) samples were positive for HIV DNA by PCR. This equates to 9.2% (54/584) of all infants tested. The majority of mothers interviewed said they were comfortable with testing of their infant at immunization clinics and would recommend it to others. Conclusion:Screening of all infants at immunization clinics is acceptable and feasible as a means for early identification of HIV-infected infants and referral for antiretroviral therapy.

HIV-related stigma, social norms, and HIV testing in Soweto and Vulindlela, South Africa: National Institutes of Mental Health Project Accept (HPTN 043).

Objective:HIV testing is necessary to curb the increasing epidemic. However, HIV-related stigma and perceptions of low likelihood of societal HIV testing may reduce testing rates. This study aimed to explore this association in South Africa, where HIV rates are extraordinarily high. Methods:Data were taken from the Soweto and Vulindlela, South African sites of Project Accept, a multinational HIV prevention trial. Self-reported HIV testing, stigma, and social norms items were used to study the relationship between HIV testing, stigma, and perceptions about societal testing rates. The stigma items were broken into 3 factors: negative attitudes, negative perceptions about people living with HIV, and perceptions of fair treatment for people living with HIV (equity). Results:Results from a univariate logistic regression suggest that history of HIV testing was associated with decreased negative attitudes about people living with HIV/AIDS, increased perceptions that people living with HIV/AIDS experience discrimination, and increased perceptions that people with HIV should be treated equitably. Results from a multivariate logistic regression confirm these effects and suggest that these differences vary according to sex and age. Compared with people who had never tested for HIV, those who had previously tested were more likely to believe that the majority of people have tested for HIV. Conclusions:Data suggest that interventions designed to increase HIV testing in South Africa should address stigma and perceptions of societal testing.

Effect of community-based voluntary counselling and testing on HIV incidence and social and behavioural outcomes (NIMH Project Accept; HPTN 043): a cluster-randomised trial

BACKGROUND Although several interventions have shown reduced HIV incidence in clinical trials, the community-level effect of effective interventions on the epidemic when scaled up is unknown. We investigated whether a multicomponent, multilevel social and behavioural prevention strategy could reduce HIV incidence, increase HIV testing, reduce HIV risk behaviour, and change social and behavioural norms. METHODS For this phase 3 cluster-randomised controlled trial, 34 communities in four sites in Africa and 14 communities in Thailand were randomly allocated in matched pairs to receive 36 months of community-based voluntary counselling and testing for HIV (intervention group) or standard counselling and testing alone (control group) between January, 2001, and December, 2011. The intervention was designed to make testing more accessible in communities, engage communities through outreach, and provide support services after testing. Randomisation was done by a computer-generated code and was not masked. Data were collected at baseline (n=14 567) and after intervention (n=56.683) by cross-sectional random surveys of community residents aged 18-32 years. The primary outcome was HIV incidence and was estimated with a cross-sectional multi-assay algorithm and antiretroviral drug screening assay. Thailand was excluded from incidence analyses because of low HIV prevalence. This trial is registered at ClinicalTrials.gov, number NCT00203749. FINDINGS The estimated incidence of HIV in the intervention group was 1.52% versus 1.81% in the control group with an estimated reduction in HIV incidence of 13.9% (relative risk [RR] 0.86, 95% CI 0.73-1.02; p=0.082). HIV incidence was significantly reduced in women older than 24 years (RR=0.70, 0.54-0.90; p=0.0085), but not in other age or sex subgroups. Community-based voluntary counselling and testing increased testing rates by 25% overall (12-39; p=0.0003), by 45% (25-69; p<0·0001) in men and 15% (3-28; p=0.013) in women. No overall effect on sexual risk behaviour was recorded. Social norms regarding HIV testing were improved by 6% (95% CI 3-9) in communities in the intervention group. INTERPRETATION These results are sufficiently robust, especially when taking into consideration the combined results of modest reductions in HIV incidence combined with increases in HIV testing and reductions in HIV risk behaviour, to recommend the Project Accept approach as an integral part of all interventions (including treatment as prevention) to reduce HIV transmission at the community level. FUNDING US National Institute of Mental Health, the Division of AIDS of the US National Institute of Allergy and Infectious Diseases, and the Office of AIDS Research of the US National Institutes of Health.

Test and Tell: Correlates and Consequences of Testing and Disclosure of HIV Status in South Africa (HPTN 043 Project Accept)

Background:As the numbers of HIV-positive diagnoses rise in South Africa, it is important to understand the determinants and consequences of HIV disclosure. Methods:Cross-sectional survey from random community samples of men and women in urban and rural South Africa (n = 217 HIV-positive individuals, 89% female). Results:Two thirds of all known HIV-infected adults in these communities had disclosed their status to sexual partner(s). On average, individuals who disclosed were 2 years older, higher in socioeconomic assets, and had known their HIV status 7 months longer than those who had not told their sexual partner(s). The “need for privacy” was the most cited reason (45%) for nondisclosure among those who had never disclosed. People who eventually disclosed their HIV status to sexual partner(s) were significantly more likely to report always or more frequently using condoms, reducing their number of sexual partners, and/or becoming monogamous. Among individuals who disclosed their HIV status, 77% reported increases in social support, with families providing the most support. Conclusions:Disclosure is associated with reports of consequent safer sexual behavior and greater social support. Interventions might be informed by the costs and benefits of disclosure and differences in disclosure to sexual partner vs. to ones social network.

Initiation of antiretroviral therapy and viral suppression after home HIV testing and counselling in KwaZulu-Natal, South Africa, and Mbarara district, Uganda: a prospective, observational intervention study

OBJECTIVE 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. METHODS 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). FINDINGS 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. INTERPRETATION 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.

Rethinking HIV prevention to prepare for oral PrEP implementation for young African women

HIV incidence remains high among young women in sub‐Saharan Africa in spite of scale‐up of HIV testing, behavioural interventions, antiretroviral treatment and medical male circumcision. There is a critical need to critique past approaches and learn about the most effective implementation of evidence‐based HIV prevention strategies, particularly emerging interventions such as pre‐exposure prophylaxis (PrEP).

HIV Status Disclosure to Families for Social Support in South Africa (NIMH Project Accept/ HPTN 043)

Literature on HIV status disclosure among persons living with HIV/AIDS (PLWHA) is dominated by research on the rates, barriers and consequences of disclosure to sexual partners, because of the assumed preventive health benefits of partner disclosure. Disclosure of HIV status can lead to an increase in social support and other positive psychosocial outcomes for PLWHA, but disclosure can also be associated with negative social outcomes including stigma, discrimination, and violence. The purpose of this article is to describe the HIV status disclosure narratives of PLWHA living in South Africa. Thirty in-depth interviews were conducted with 13 PLWHA (11 women, 2 men) over a three-year period. We explored disclosure narratives of the PLWHA through questions about who they chose to disclose to, how they disclosed to these individuals, and how these individuals reacted. Narratives focused on disclosure to family members and contained relatively little discussion of disclosure to sexual partners. Participants often disclosed first to one trusted family member, and news of the diagnosis remained with this person for a long period of time, prior to sharing with others. This family member helped the PLWHA cope with the news of their diagnosis and prepared them to disclose to others. Disclosure to ones partner was motivated primarily by a desire to encourage partners to test for HIV. Two participants described overtly negative reactions from a partner upon disclosure, and none of the PLWHA in this sample described very supportive relationships with their partners after disclosure. The critical role that family members played in the narratives of these PLWHA emphasizes the need for a greater focus on disclosure to families for social support in HIV counseling protocols.

Uptake of antiretroviral therapy and male circumcision after community-based HIV testing and strategies for linkage to care versus standard clinic referral: a multisite, open-label, randomised controlled trial in South Africa and Uganda

BACKGROUND Male circumcision decreases HIV acquisition by 60%, and antiretroviral therapy (ART) almost eliminates HIV transmission from HIV-positive people who are virally suppressed; however, coverage of these interventions has lagged behind targets. We aimed to assess whether community-based HIV testing with counsellor support and point-of-care CD4 cell count testing would increase uptake of ART and male circumcision. METHODS We did this multisite, open-label, randomised controlled trial in six research-naive communities in rural South Africa and Uganda. Eligible HIV-positive participants (aged ≥16 years) were randomly assigned (1:1:1) in a factorial design to receive lay counsellor clinic linkage facilitation, lay counsellor follow-up home visits, or standard-of-care clinic referral, and then (1:1) either point-of-care CD4 cell count testing or referral for CD4 testing. HIV-negative uncircumcised men (aged 16-49 years) who could receive secure mobile phone text messages were randomly assigned (1:1:1) to receive text message reminders, lay counsellor visits, or standard clinic referral. The study biostatistician generated the randomisation schedule via a computer-generated random number program with varying block sizes (multiples of six or three) stratified by country. Primary outcomes for HIV-positive people were obtaining a CD4 cell count, linkage to an HIV clinic, ART initiation, and viral suppression at 9 months, and for HIV-negative uncircumcised men were visiting a circumcision facility and uptake of male circumcision at 3 months. We assessed social harms as a safety outcome throughout the study. We did the primary analyses by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02038582. FINDINGS Between June 6, 2013, and March 11, 2015, 15 332 participants were tested. 2339 (15%) participants tested HIV positive, of whom 1325 (57%) were randomly assigned to receive lay counsellor clinic linkage facilitation (n=437), lay counsellor follow-up home visits (n=449), or standard clinic referral (n=439), and then point-of-care CD4 cell testing (n=206, n=220, and n=213, respectively) or referral for CD4 testing (n=231, n=229, and n=226, respectively). 12 993 (85%) participants tested HIV negative, of whom 750 (6%) uncircumcised men were randomly assigned to receive clinic referral (n=230), text message reminders (n=288), or lay counsellor follow-up visits (n=232). 1218 (93%) of 1303 HIV-positive participants were linked to care, but only 488 (37%) participants initiated ART. Overall, 635 (50%) of 1272 HIV-positive individuals achieved viral suppression at 9 months: 219 (52%) of 419 participants in the clinic facilitation group, 202 (47%) of 431 participants in the lay counsellor follow-up group, and 214 (51%) of 422 participants in the clinic referral group, with no significant differences between groups (p=0·668 for clinic facilitation and p=0·273 for lay counsellor follow-up vs clinic referral). 523 (72%) of 734 HIV-negative men visited a circumcision facility, with no difference between groups. 62 (28%) of 224 men were circumcised in the male circumcision clinic referral group compared with 137 (48%) of 284 men in the text message reminder group (relative risk 1·72, 95% CI 1·36-2·17; p<0·0001) and 106 (47%) of 226 men in the lay counsellor follow-up group (1·67, 1·29-2·14; p=0·0001). No cases of study-related social harm were reported, including probing about partnership separation, unintended disclosure, gender-based violence, and stigma. INTERPRETATION All the community-based strategies achieved high rates of linkage of HIV-positive people to HIV clinics, roughly a third of whom initiated ART, and of those more than 80% were virally suppressed at 9 months. Uptake of male circumcision was almost two-times higher in men who received text message reminders or lay counsellor visits than in those who received standard-of-care clinic referral. Clinic barriers to ART initiation should be addressed in future strategies to increase the proportion of HIV-positive people accessing treatment and achieving viral suppression. FUNDING National Institute of Allergy and Infectious Diseases, National Institutes of Health.

The influence of antiretroviral treatment on willingness to test: a qualitative study in rural KwaZulu-Natal, South Africa

Previous quantitative studies suggest a mutually reinforcing relationship between HIV counselling and testing (HCT) and antiretroviral treatment (ART). HCT is the entry into ART, and access to ART appears to increase HIV-testing uptake in settings with historically low uptake. Adopting a qualitative approach, this study examined the influence of ART on willingness to test for HIV, in a rural community in South Africa. Ninety-six in-depth interviews from a large community-based HIV-prevention trial were analysed. The data provide insight into the community members’ views, perceptions and experiences regarding ART, and how they draw on these in making decisions about HIV testing. Several key factors that supported a positive relationship between ART and HIV testing were noted. These included the beliefs that ART brings hope and that it prolongs life; the powerful positive effect of witnessing the recovery of someone on treatment; and that ART encourages early HIV-testing behaviour. A few negative factors that could potentially weaken the effects of this positive relationship between ART and HCT uptake were the disclosure difficulties experienced by those enrolled in treatment, beliefs that ART does not cure HIV disease, and the travel distance to testing and treatment facilities from where people live and work. HIV/AIDS-service providers and programme planners should actively draw on these observations, to encourage increased HIV testing in communities and to ensure that the maximum number of people get the HIV treatment and care services that they require.