Two-way associations between relationship quality and uptake of couples health screening including HIV testing and counselling together: quantitative analysis of a couples cohort in rural South Africa.

In the context of a couples cohort established to evaluate an optimised couples-focused behavioural intervention in rural South Africa, we examined: (1) Is couples' relationship quality (RQ) associated with couples HIV testing and counselling (CHTC) uptake? (2) Does CHTC uptake or the intervention components uptake improve subsequent RQ? Enrolled couples, (n = 218), previously naïve to couples HIV testing, were invited to two group sessions and offered four couples counselling sessions (CS1-CS4), as part of the intervention and administered a questionnaire individually at baseline, four weeks, and four months, which included item-scales to measure RQ: satisfaction, intimacy, dyadic trust, conflict, and mutual constructive communication. Logistic models indicated that no baseline RQ measures were significantly associated with CHTC uptake. Linear regression models showed that CHTC uptake before four weeks assessment significantly improved couples' satisfaction and trust at four weeks, and intimacy at four months. Attending at least one CS was associated with increased satisfaction, intimacy, and decreased conflict within couples at four weeks; the improvement in intimacy was sustained at four months. Consistent with the theoretical interdependence model, our findings suggest that CHTC and CS seemed to strengthen aspects of relationship quality, possibly leading to further collaboration in managing lifestyle changes and treatment adherence.

People living with HIV's perspectives of acceptability of fee for home delivery of ART: a qualitative study.

INTRODUCTION: Significant progress has been made in the HIV response in South Africa; however, gaps remain in ensuring engagement in care to support life-long medication adherence and viral suppression. The National Department of Health (NDoH) has introduced community-based and clinic-based HIV differentiated service delivery (DSD) models to tackle suboptimal adherence and retention in care. Nevertheless, differentiated care models require adaptation to better serve clients who struggle with adherence. There is limited research on the acceptability of fee for home delivery of ART in resource-constrained settings. The current study investigates the acceptability of fee for home delivery of ART among people living with HIV in South Africa. METHODS: Two mixed-gender focus group discussions (FGDs) took place between June and November 2019, consisting of 10 participants in each group. A purposive sampling strategy was employed to identify and select 10 people living with HIV who were ART-eligible but not in care, and 10 people living with HIV who were currently taking ART and in care. Participants were grouped according to their treatment status. A coding framework, informed by a priori categories and derived from topics in the interview guide, was developed and utilized to facilitate analysis. RESULTS: Participants expressed enthusiasm for having ART home-delivered, as it would save the time spent waiting in long queues at the clinic. However, some participants raised concerns about potential payment difficulties due to high unemployment rates in the community. Some participants believed this would be acceptable, as patients already incur costs for travel and food when visiting the clinic. Participants in both FGDs expressed strong concerns about home delivery of their ART based on fear of accidental disclosure, especially for those who have not disclosed to their immediate families and partners. CONCLUSION: Our study suggests that charging a fee for home delivery is an acceptable and innovative approach to supporting PLHIV in maintaining adherence to their medication and remaining in care.

Protocol: evaluation of an optimised couples-focused intervention to increase testing for HIV in rural KwaZulu-Natal, South Africa, the Igugu Lethu ('Our treasure') cohort study.

BACKGROUND: Between 2012 and 2015, the Uthando Lwethu (UL) study demonstrated that a theory-based behavioural couples-focused intervention significantly increased participation in couples HIV testing and counselling (CHTC) among South African couples who had never previously tested for HIV together or mutually disclosed their HIV status, 42% compared to 12% of the control group at 9 months follow-up. Although effective, we were nonetheless concerned that in this high prevalence setting the majority (58%) of intervention couples chose not to test together. In response we optimised the UL intervention and in a new study, 'Igugu Lethu', we are evaluating the success of the optimised intervention in promoting CHTC. METHODS: One hundred eighty heterosexual couples, who have been in a relationship together for at least 6 months, are being recruited and offered the optimised couples-focused intervention. In the Igugu Lethu study, we have expanded the health screening visit offered to couples to include other health conditions in addition to CHTC. Enrolled couples who choose to schedule CHTC will also have the opportunity to undertake a random blood glucose test, blood pressure and BMI measurements, and self-sample for STI testing as part of their health screening. Individual surveys are administered at baseline, 4 weeks and 4 months follow-up. The proportion of couples who decide to test together for HIV will be compared to the results of the intervention arm in the UL study (historical controls). To facilitate this comparison, we will use the same recruitment and follow-up strategies in the same community as the previous UL study. DISCUSSION: By strengthening communication and functioning within the relationship, the Igugu Lethu study, like the previous UL study, aims to transform the motivation of individual partners from a focus on their own health to shared health as a couple. The Igugu Lethu study findings will answer whether the optimised couples-focused behavioural intervention and offering CHTC as part of a broader health screening for couples can increase uptake of CHTC by 40%, an outcome that would be highly desirable in populations with high HIV prevalence. TRIAL REGISTRATION: Retrospectively registered. ISRCTN Registry ISRCTN 46162564 Registered on 26th May 2022.

Optimising a couples-focused intervention to increase couples' HIV testing and counselling using the person-based approach: a qualitative study in Kwa-Zulu Natal, South Africa.

OBJECTIVES: This qualitative study explored how to optimise a couples-focused intervention to promote couples HIV testing and counselling (CHTC). SETTING: Community setting in Kwa-Zulu Natal, South Africa. PARTICIPANTS: Qualitative interviews were conducted with 20 couples who had participated in a couples-focused intervention and five staff members delivering the intervention. Partners were interviewed individually by researchers of the same gender. INTERVENTION: A couples-focused intervention comprised of two group sessions and four couples counselling sessions was previously shown to significantly increase uptake to CHTC in Kwa-Zulu Natal, South Africa. However, more than half of couples participating in the intervention still chose not to test together during follow-up. ANALYSIS: The transcripts were analysed using the table of changes from the person-based approach. Proposed optimisations were discussed with a community group to ensure the intervention was as persuasive and acceptable as possible. RESULTS: Many couples found it challenging to discuss CHTC with their partner due to an implied lack of trust. Optimisations to the intervention were identified to increase readiness to discuss CHTC, including education about serodiscordance, discussions about CHTC by peer mentors and open discussion of personal barriers to CHTC during couples' counselling sessions. Additional training for staff in open questioning techniques could help them feel more comfortable to explore couples' perceived barriers to CHTC, rather than advising couples to test. A logic model was developed to show anticipated mechanisms through which the optimised intervention would increase uptake to CHTC, including increasing knowledge, increasing positive outcome beliefs and managing negative emotions. CONCLUSIONS: In-depth qualitative research informed optimisations to a couples-focused intervention for further evaluation in South Africa to encourage uptake to CHTC. Suggestions are made for optimal methods to gain open feedback on intervention experiences where participants may be reluctant to share negative views.

Does peer-navigated linkage to care work? A cross-sectional study of active linkage to care within an integrated non-communicable disease-HIV testing centre for adults in Soweto, South Africa.

INTRODUCTION: South Africa is the HIV epidemic epicentre; however, non-communicable diseases (NCDs) will be the most common cause of death by 2030. To improve identification and initiation of care for HIV and NCDs, we assessed proportion of clients referred and linked to care (LTC) for abnormal/positive screening results and time to LTC and treatment initiation from a HIV Testing Services (HTS) Centre before and after integrated testing for NCDs with optional peer-navigated linkage to care. MATERIALS AND METHODS: This two-phase prospective study was conducted at an adult HTS Centre in Soweto, South Africa. Phase 1 (February-June 2018) utilised standard of care (SOC) HTS services (blood pressure [BP], HIV rapid diagnostic testing (RDT), sexually transmitted infections [STI]/Tuberculosis [TB] symptom screening) with passive referral for abnormal/positive results. Phase 2 (June 2018-March 2019) further integrated blood glucose/cholesterol/chlamydia RDT, with optional peer-navigated referral. Enrolled referred clients completed telephonic follow-up surveys confirming LTC/treatment initiation ≤3 months post-screening. Socio-demographics, screening results, time to LTC/treatment initiation, peer-navigated referral uptake were reported. Analysis included Fisher's exact, chi-squared, Kruskal Wallis, and Student's T-tests. Thematic analysis was conducted for open-ended survey responses. RESULTS: Of all 320 referrals, 40.0% were HIV-infections, 11.9% STIs, 6.6% TB, and 28.8% high/low BP. Of Phase 2-only referrals, 29.4% were for glucose and 23.5% cholesterol. Integrated NCD-HTS had significantly more clients LTC for HIV (76.7%[n = 66/86] vs 52.4%[n = 22/42], p = 0.0052) and within a shorter average time (6-8 days [Interquartile range (IQR):1-18.5] vs 8-13 days [IQR:2-32]) as compared to SOC HTS. Integrated NCD-HTS clients initiated HIV/STIs/BP treatment on average more quickly as compared to SOC HTS (5 days for STIs [IQR:1-21], 8 days for HIV/BP [IQR:5-17 and 2-13, respectively] vs 10 days for STIs [IQR: 4-32], 19.5 days for HIV [IQR:6.5-26.5], 8 days for BP [IQR:2-29)]. Participants chose passive over active referral (89.1% vs 10.9%; p<0.0001). Participants rejecting peer-navigated referral preferred to go alone (55.7% [n = 39/70]). Non-LTC was due to being busy (41.1% [n = 39/95]) and not being ready/refusing treatment (31.6% [n = 30/95]). Normalised results assessed at referral clinic (49.7% [n = 98/196]), prescribed lifestyle modification/monitoring (30.9% [n = 61/196]), and poor clinic flow/congestion and/or further testing required (10.7% [n = 21/196]) were associated with non-treatment initiation. CONCLUSION: Same-day treatment initiation is not achieved across diseases, despite peer-navigated referral. There are psychosocial and health systems barriers at entry to care/treatment initiation. Additional research may identify best strategies for rapid treatment initiation.

Results of a Couples-Based Randomized Controlled Trial Aimed to Increase Testing for HIV.

BACKGROUND: Although couples HIV testing and counseling (CHTC) is effective for facilitating mutual disclosure and linkage to HIV care, uptake remains low. Using a randomized controlled design, we tested the efficacy of a behavioral couples-based intervention aimed to increase CHTC. SETTING: The Vulindlela district of KwaZulu-Natal, South Africa. METHODS: Couples were recruited from the community (eg, markets and community events). Couples were excluded if mutual HIV serostatus disclosure had occurred. Both partners had to report being each other's primary partner and relationship length was at least 6 months. Assessments occurred at baseline, and 3, 6, and 9 months after intervention. Eligible couples attended a group session (3-4 hours) after which randomization occurred. Intervention couples additionally received: one couples-based group session followed by 4 couples' counseling sessions (1-2 hours). Intervention topics included communication skills, intimate partner violence, and HIV prevention. Our primary outcomes were CHTC and sexual risk behavior. RESULTS: Overall, 334 couples were enrolled. Intervention couples were significantly more likely to have participated in CHTC [42% vs. 12% (P ≤ 0.001)]. In addition, their time to participate in CHTC was significantly shorter (logrank P ≤ 0.0001) (N = 332 couples). By group, 59% of those who tested HIV-positive in intervention and 40% of those who tested in control were new HIV diagnoses (P = 0.18). There were no group differences in unprotected sex. CONCLUSIONS: Our intervention improved CHTC uptake-a vehicle for mutual serostatus disclosure and entrée into HIV treatment, both of which exert a significant public health impact on communities substantially burdened by HIV.

Zwakala Ndoda: a cluster and individually randomized trial aimed at improving testing, linkage, and adherence to treatment for hard-to reach men in KwaZulu-Natal, South Africa.

BACKGROUND: Men in sub-Saharan Africa are less likely than women to get tested for HIV, less likely to present for treatment, less likely to be maintained in treatment, more likely to have detectable viral load, more likely to transmit HIV with unprotected intercourse, and more likely to progress to AIDS and die sooner from HIV. The ultimate objective of this research is to provide evidence-based strategies to improve HIV testing and treatment of HIV-infected men. METHODS: This study is being conducted in the Greater Edendale Area and Vulindlela region in KwaZulu-Natal, South Africa. It is a two-stage design of a cluster-randomized trial and an individual randomized trial to test how structural and individual-level interventions address the demand-side factors that affect HIV testing and treatment for hard-to reach, high-risk men. It combines male-focused mobilization, community-based mobile HIV testing services, and a small incentive to determine if the strategies singly and in combination can result in more men diagnosed with HIV, and more men linked to and maintained in care with undetectable viral load. DISCUSSION: A priority for sub-Sahara Africa is developing and evaluating novel and cost-effective strategies for identifying hard-to-reach groups such as men, linking them to HIV testing and care services, and maintaining them in care to the point of viral suppression. We propose a combination prevention intervention that addresses men's individual, interpersonal, and structural barriers to testing and care. This includes male-led mobilization to encourage uptake of testing and treatment, male-focused testing venues, male-only counselors, developing counseling models that are flexible and responsive to men, and strategies for adhering to clinic visits without missing work and navigating the healthcare system. By thoughtfully combining male-focused mobilization, and testing and addressing some of the barriers to male engagement with health facilities, this study hopes to add to the growing evidence base about how to reach, test, link, and maintain a hard-to-reach group such as men in HIV treatment and care services. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03794245. Registered on 4 January 2019.

Cost of Integrating Noncommunicable Disease Screening Into Home-Based HIV Testing and Counseling in South Africa.

INTRODUCTION: Integrated HIV-noncommunicable disease (NCD) services have the potential to avert death and disability but require data on program costs to assess the impact of integrated services on affordability. METHODS: We estimated the incremental costs of NCD screening as part of home-based HIV testing and counseling (HTC) and referral to care in KwaZulu-Natal, South Africa. All adults in the households were offered integrated HIV-NCD screening (for HIV, diabetes, hypertension, hypercholesterolemia, obesity, depression, tobacco, and alcohol use), counseling, and linkage to care. We conducted comprehensive program microcosting including ingredient-based and activity-based costing, staff interviews, and time assessment studies. Sensitivity analyses varied cost inputs and screening efficiency. RESULTS: Integrating all-inclusive NCD screening as part of home-based HTC in a high HIV prevalence setting increased program costs by $3.95 (42%) per person screened (from $9.36 to $13.31 per person). Integrated NCD screening, excluding point-of-care cholesterol testing, increased program costs by $2.24 (24%). Furthermore, NCD screening integrated into HTC services reduced the number of persons tested by 15%-20% per day. CONCLUSIONS: Integrated HIV-NCD screening has the potential to efficiently use resources compared with stand-alone services. Although all-inclusive NCD screening could increase the incremental cost per person screened for integrated HIV-NCD services over 40%, a less costly lipid assay or targeted screening would result in a modest increase in costs with the potential to avert NCD death and disability. Our analysis highlights the need for implementation science studies to estimate the cost-effectiveness of integrated HIV-NCD screening and linkage per disability-adjusted life year and death averted.

How home HIV testing and counselling with follow-up support achieves high testing coverage and linkage to treatment and prevention: a qualitative analysis from Uganda.

INTRODUCTION: The successes of HIV treatment scale-up and the availability of new prevention tools have raised hopes that the epidemic can finally be controlled and ended. Reduction in HIV incidence and control of the epidemic requires high testing rates at population levels, followed by linkage to treatment or prevention. As effective linkage strategies are identified, it becomes important to understand how these strategies work. We use qualitative data from The Linkages Study, a recent community intervention trial of community-based testing with linkage interventions in sub-Saharan Africa, to show how lay counsellor home HIV testing and counselling (home HTC) with follow-up support leads to linkage to clinic-based HIV treatment and medical male circumcision services. METHODS: We conducted 99 semi-structured individual interviews with study participants and three focus groups with 16 lay counsellors in Kabwohe, Sheema District, Uganda. The participant sample included both HIV+ men and women (N=47) and HIV-uncircumcised men (N=52). Interview and focus group audio-recordings were translated and transcribed. Each transcript was summarized. The summaries were analyzed inductively to identify emergent themes. Thematic concepts were grouped to develop general constructs and framing propositional statements. RESULTS: Trial participants expressed interest in linking to clinic-based services at testing, but faced obstacles that eroded their initial enthusiasm. Follow-up support by lay counsellors intervened to restore interest and inspire action. Together, home HTC and follow-up support improved morale, created a desire to reciprocate, and provided reassurance that services were trustworthy. In different ways, these functions built links to the health service system. They worked to strengthen individuals' general sense of capability, while making the idea of accessing services more manageable and familiar, thus reducing linkage barriers. CONCLUSIONS: Home HTC with follow-up support leads to linkage by building "social bridges," interpersonal connections established and developed through repeated face-to-face contact between counsellors and prospective users of HIV treatment and male circumcision services. Social bridges link communities to the service system, inspiring individuals to overcome obstacles and access care.

Home testing and counselling to reduce HIV incidence in a generalised epidemic setting: a mathematical modelling analysis.

BACKGROUND: Home HIV testing and counselling (HTC) achieves high levels of HIV testing and linkage to care. Periodic home HTC, particularly targeted to those with high HIV viral load, might facilitate expansion of antiretroviral therapy (ART) coverage. We used a mathematical model to assess the effect of periodic home HTC programmes on HIV incidence in KwaZulu-Natal, South Africa. METHODS: We developed a dynamic HIV transmission model with parameters, primary cost data, and measures of viral suppression collected from a prospective study of home HTC in KwaZulu-Natal. In our model, we assumed home HTC took place every 5 years with ART initiation for people with CD4 counts of 350 cells per µL or less. For individuals with CD4 counts of more than 350 cells per µL, we compared increasing ART coverage for those with 350-500 cells per µL with initiating treatment for those who have viral loads of more than 10 000 copies per mL. FINDINGS: Maintaining the presently observed level of 36% viral suppression in HIV-positive people, HIV incidence decreases by 33·8% over 10 years. Home HTC every 5 years with linkage to care with ART initiation at CD4 counts of 350 cells per µL or less reduces HIV incidence by 40·6% over 10 years. Expansion of ART to people with CD4 counts of more than 350 cells per µL who also have a viral load of 10 000 copies per mL or more decreases HIV incidence by 51·6%, and this was the most cost-effective strategy for prevention of HIV infections at US$2960 per infection averted. Expansion of ART eligibility CD4 counts of 350-500 cells per µL is cost-effective at $900 per quality-adjusted life-year gained. Following health economic guidelines, expansion of ART use to individuals who have viral loads of more than 10 000 copies per mL among those with CD4 counts of more than 350 cells per µL was cost-effective to reduce HIV-related morbidity. INTERPRETATION: Our results show that province-wide home HTC every 5 years can be a cost-effective strategy to increase ART coverage and reduce HIV burden. Expanded ART initiation criteria that includes individuals with high viral load will improve the effectiveness of home HTC in linking individuals to ART who are at high risk of transmitting HIV, thereby preventing morbidity and onward transmission. FUNDING: National Institutes of Health.

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.

Evaluation of the HIV lay counselling and testing profession in South Africa.

BACKGROUND: With the launch of the national HIV Counselling and Testing (HCT) campaign in South Africa (SA), lay HIV counsellors, who had been trained in blood withdrawal, have taken up the role of HIV testing. This study evaluated the experiences, training, motivation, support, supervision, and workload of HIV lay counsellors and testers in South Africa. The aim was to identify gaps in their resources, training, supervision, motivation, and workload related to HCT services. In addition it explored their experiences with providing HIV testing under the task shifting context. METHODS: The study was conducted in eight of South Africa's nine provinces. 32 lay counsellors were recruited from 67 HCT sites, and were interviewed using two questionnaires that included structured and semi-structured questions. One questionnaire focused on their role as HIV counsellors and the other on their role as HIV testers. RESULTS: Ninety-seven percent of counsellors reported that they have received training in counselling and testing. Many rated their training as more than adequate or adequate, with 15.6% rating it as not adequate. Respondents reported a lack of standardised counselling and testing training, and revealed gaps in counselling skills for specific groups such as discordant couples, homosexuals, older clients and children. They indicated health system barriers, including inadequate designated space for counselling, which compromises privacy and confidentiality. Lay counsellors carry the burden of counselling and testing nationally, and have other tasks such as administration and auxiliary duties due to staff shortages. CONCLUSIONS: This study demonstrates that HCT counselling and testing services in South Africa are mainly performed by lay counsellors and testers. They are challenged by inadequate work space, limited counselling skills for specific groups, a lack of standardised training policies and considerable administrative and auxiliary duties. To improve HCT services, there needs to be training needs with a standardised curriculum and refresher courses, for HIV counselling and testing, specifically for specific elderly clients, discordant couples, homosexuals and children. The Department of Health should formally integrate lay counsellors into the health care system with proper allocation of tasks under the task shifting policy.

Cost-effectiveness of community-based strategies to strengthen the continuum of HIV care in rural South Africa: a health economic modelling analysis.

BACKGROUND: Home HIV counselling and testing (HTC) achieves high coverage of testing and linkage to care compared with existing facility-based approaches, particularly among asymptomatic individuals. In a modelling analysis we aimed to assess the effect on population-level health and cost-effectiveness of a community-based package of home HTC in KwaZulu-Natal, South Africa. METHODS: We parameterised an individual-based model with data from home HTC and linkage field studies that achieved high coverage (91%) and linkage to antiretroviral therapy (80%) in rural KwaZulu-Natal, South Africa. Costs were derived from a linked microcosting study. The model simulated 10,000 individuals over 10 years and incremental cost-effectiveness ratios were calculated for the intervention relative to the existing status quo of facility-based testing, with costs discounted at 3% annually. FINDINGS: The model predicted implementation of home HTC in addition to current practice to decrease HIV-associated morbidity by 10­22% and HIV infections by 9­48% with increasing CD4 cell count thresholds for antiretroviral therapy initiation. Incremental programme costs were US$2·7 million to $4·4 million higher in the intervention scenarios than at baseline, and costs increased with higher CD4 cell count thresholds for antiretroviral therapy initiation; antiretroviral therapy accounted for 48­87% of total costs. Incremental cost-effectiveness ratios per disability-adjusted life-year averted were $1340 at an antiretroviral therapy threshold of CD4 count lower than 200 cells per µL, $1090 at lower than 350 cells per µL, $1150 at lower than 500 cells per µL, and $1360 at universal access to antiretroviral therapy. INTERPRETATION: Community-based HTC with enhanced linkage to care can result in increased HIV testing coverage and treatment uptake, decreasing the population burden of HIV-associated morbidity and mortality. The incremental cost-effectiveness ratios are less than 20% of South Africa's gross domestic product per person, and are therefore classed as very cost effective. Home HTC can be a viable means to achieve UNAIDS' ambitious new targets for HIV treatment coverage. FUNDING: National Institutes of Health, Bill & Melinda Gates Foundation, Wellcome Trust.

What should the ideal HIV self-test look like? A usability study of test prototypes in unsupervised HIV self-testing in Kenya, Malawi, and South Africa.

HIV self-testing (HIVST) is increasingly being sought and offered globally, yet there is limited information about the test features that will be required for an HIV self-test to be easy to use, acceptable to users, and feasible for manufacturers to produce. We conducted formative usability research with participants who were naïve to HIVST using five prototypes in Kenya, Malawi, and South Africa. The tests selected ranged from early-stage prototypes to commercially ready products and had a diverse set of features. A total of 150 lay users were video-recorded conducting unsupervised self-testing and interviewed to understand their opinions of the test. Participants did not receive a test result, but interpreted standardized result panels. This study demonstrated that users will refer to the instructions included with the test, but these can be confusing or difficult to follow. Errors were common, with less than 25% of participants conducting all steps correctly and 47.3% of participants performing multiple errors, particularly in sample collection and transfer. Participants also had difficulty interpreting results. To overcome these issues, the ideal HIV self-test requires pictorial instructions that are easy to understand, simple sample collection with integrated test components, fewer steps, and results that are easy to interpret.

Uthando Lwethu ('our love'): a protocol for a couples-based intervention to increase testing for HIV: a randomized controlled trial in rural KwaZulu-Natal, South Africa.

BACKGROUND: Couples-based HIV counseling and testing (CHCT) is a proven strategy to reduce the risk of HIV transmission between partners, but uptake of CHCT is low. We describe the study design of a randomized controlled trial (RCT) aimed to increase participation in CHCT and reduce sexual risk behavior for HIV among heterosexual couples in rural KwaZulu-Natal, South Africa. We hypothesize that the rate of participation in CHCT will be higher and sexual risk behavior will be lower in the intervention group as compared to the control. METHODS/DESIGN: Heterosexual couples (N=350 couples, 700 individuals) are being recruited to participate in a randomized trial of a couples-based intervention comprising two group sessions (one mixed gender, one single gender) and four couples' counseling sessions. Couples must have been in a relationship together for at least 6 months. Quantitative assessments are conducted via mobile phones by gender-matched interviewers at baseline, 3, 6, and 9 months post-randomization. Intervention content is aimed to improve relationship dynamics, and includes communication skills and setting goals regarding CHCT. DISCUSSION: The Uthando Lwethu ('our love') intervention is the first couples-based intervention to have CHCT as its outcome. We are also targeting reductions in unprotected sex. CHCT necessitates the testing and mutual disclosure of both partners, conditions that are essential for improving subsequent outcomes such as disclosure of HIV status, sexual risk reduction, and improving treatment outcomes. Thus, improving rates of CHCT has the potential to improve health outcomes for heterosexual couples in a rural area of South Africa that is highly impacted by HIV. The results of our ongoing clinical trial will provide much needed information regarding whether a relationship-focused approach is effective in increasing rates of participation in CHCT. Our intervention represents an attempt to move away from individual-level conceptualizations, to a more integrated approach for HIV prevention. TRIAL REGISTRATION: Study Name: Couples in Context: An RCT of a Couples-based HIV Prevention InterventionClinicalTrials.gov identifier: NCT01953133.South African clinical trial registration number: DOH-27-0212-3937.

High HIV testing uptake and linkage to care in a novel program of home-based HIV counseling and testing with facilitated referral in KwaZulu-Natal, South Africa.

OBJECTIVE: For antiretroviral therapy (ART) to have a population-level HIV prevention impact, high levels of HIV testing and effective linkages to HIV care among HIV-infected persons are required. METHODS: We piloted home-based counseling and testing (HBCT) with point-of-care CD4 count testing and follow-up visits to facilitate linkage of HIV-infected persons to local HIV clinics and uptake of ART in rural KwaZulu-Natal, South Africa. Lay counselor follow-up visits at months one, three and six evaluated the primary outcome of linkage to care. Plasma viral load was measured at baseline and month six. RESULTS: 671 adults were tested for HIV (91% coverage) and 201 (30%) were HIV-infected, of which 73 (36%) were new diagnoses. By month three, 90% of HIV-infected persons not on ART at baseline had visited an HIV clinic and 80% of those eligible for ART at baseline by South African guidelines (CD4≤200 cells/µL at the time of the study) had initiated ART. Among HIV-infected participants who were eligible for ART at baseline, mean viral load decreased by 3.23 log10 copies/mL (p<0.001) and the proportion with viral load suppression increased from 20% to 80% between baseline and month six. CONCLUSIONS: In this pilot of HBCT and linkages to care in KwaZulu-Natal, 91% of adults were tested for HIV. Linkage to care was ∼90% both among newly-identified HIV-infected persons as well as known HIVinfected persons who were not engaged in care. Among those eligible for ART, a high proportion initiated ART and achieved viral suppression, indicating high adherence and reduced infectiousness.

Alcohol consumption among HIV-positive pregnant women in KwaZulu-Natal, South Africa: prevalence and correlates.

BACKGROUND: HIV-positive pregnant women who drink put their children at risk of both HIV and fetal alcohol spectrum disorders. The province of KwaZulu-Natal (KZN) has the highest prevalence of HIV in South Africa, but has not before been considered an area of high alcohol consumption among women. This paper analyzes a large sample of HIV+ pregnant women in KZN to examine alcohol consumption in that population. METHODS: Data came from assessments of women enrolled in Prevention of Mother-To-Child Transmission programs at 8 clinics in KZN. Descriptive statistics and logistic regressions were used to examine the prevalence and correlates of alcohol consumption and binge drinking. RESULTS: Of 1201 women assessed, 18% reported drinking during pregnancy, and 67% of drinkers usually binged when drinking (had 3+ drinks in one sitting). Over one-third of drinkers binged twice a month or more. Women living in urban and peri-urban locations were more likely to drink, as were those with indicators of higher economic status and greater social engagement. Married women were less likely to drink, while women who had poorer mental health, used tobacco, or had a greater history of sexual risk-taking were more likely to drink. CONCLUSION: Health care workers in KZN should be aware that pregnant women who drink are likely to do so at a level that is dangerous for their babies. Some factors associated with drinking indicate social/environmental influences that need to be counteracted by greater dissemination of information about the dangers of drinking, and greater support for abstinence or moderation.

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.

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.