Population health impact, cost-effectiveness, and affordability of community-based HIV treatment and monitoring in South Africa: A health economics modelling study.

Community-based delivery and monitoring of antiretroviral therapy (ART) for HIV has the potential to increase viral suppression for individual- and population-level health benefits. However, the cost-effectiveness and budget impact are needed for public health policy. We used a mathematical model of HIV transmission in KwaZulu-Natal, South Africa, to estimate population prevalence, incidence, mortality, and disability-adjusted life-years (DALYs) from 2020 to 2060 for two scenarios: 1) standard clinic-based HIV care and 2) five-yearly home testing campaigns with community ART for people not reached by clinic-based care. We parameterised model scenarios using observed community-based ART efficacy. Using a health system perspective, we evaluated incremental cost-effectiveness and net health benefits using a threshold of $750/DALY averted. In a sensitivity analysis, we varied the discount rate; time horizon; costs for clinic and community ART, hospitalisation, and testing; and the proportion of the population receiving community ART. Uncertainty ranges (URs) were estimated across 25 best-fitting parameter sets. By 2060, community ART following home testing averted 27.9% (UR: 24.3-31.5) of incident HIV infections, 27.8% (26.8-28.8) of HIV-related deaths, and 18.7% (17.9-19.7) of DALYs compared to standard of care. Adolescent girls and young women aged 15-24 years experienced the greatest reduction in incident HIV (30.7%, 27.1-34.7). In the first five years (2020-2024), community ART required an additional $44.9 million (35.8-50.1) annually, representing 14.3% (11.4-16.0) of the annual HIV budget. The cost per DALY averted was $102 (85-117) for community ART compared with standard of care. Providing six-monthly refills instead of quarterly refills further increased cost-effectiveness to $78.5 per DALY averted (62.9-92.8). Cost-effectiveness was robust to sensitivity analyses. In a high-prevalence setting, scale-up of decentralised ART dispensing and monitoring can provide large population health benefits and is cost-effective in preventing death and disability due to HIV.

Messaging Circumstances and Economic Pressures as Influences on Linkage to Medical Male Circumcision following Community-Based HIV Testing for Men in Rural Southwest Uganda: A Qualitative Study.

Voluntary medical male circumcision (MMC) reduces risk of HIV infection, but uptake remains suboptimal among certain age groups and locations in sub-Saharan Africa. We analysed qualitative data as part of the Linkages Study, a randomized controlled trial to evaluate community-based HIV testing and follow-up as interventions promoting linkage to HIV treatment and prevention in Uganda and South Africa. Fifty-two HIV-negative uncircumcised men participated in the qualitative study. They participated in semistructured individual interviews exploring (a) home HTC experience; (b) responses to test results; (c) efforts to access circumcision services; (d) outcomes of efforts; (e) experiences of follow-up support; and (f) local HIV education and support. Interviews were audio-recorded, translated, transcribed, and summarized into "linkage summaries." Summaries were analysed inductively to identify the following three thematic experiences shaping men's circumcision choices: (1) intense relief upon receipt of an unanticipated seronegative diagnosis, (2) the role of peer support in overcoming fear, and (3) anticipation of missed economic productivity. Increased attention to the timing of demand creation activities, to who delivers information about the HIV prevention benefits of MMC, and to the importance of missed income during recovery as a barrier to uptake promises to strengthen and sharpen future MMC demand creation strategies.

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.

Modeling HIV disease progression and transmission at population-level: The potential impact of modifying disease progression in HIV treatment programs.

INTRODUCTION: Mathematical models that incorporate HIV disease progression dynamics can estimate the potential impact of strategies that delay HIV disease progression and reduce infectiousness for persons not on antiretroviral therapy (ART). Suppressive treatment of HIV-positive persons co-infected with herpes simplex virus-2 (HSV-2) with valacyclovir, an HSV-2 antiviral, can lower HIV viral load, but the impact of partially-suppressive valacyclovir relative to fully-suppressive ART on population HIV transmission has not been estimated. METHODS: We modeled HIV disease progression as a function of changes in viral load and CD4 count over time among ART naïve persons. The disease progression Markov model was nested within a dynamic model of HIV transmission at population level. We assumed that valacyclovir reduced HIV viral load by 1.23 log copies/µL, and that persons treated with valacyclovir initiated ART more rapidly when their CD4 fell below 500 due to retention in HIV care. We estimated the potential impact of valacyclovir on onward transmission of HIV in three scenarios of different ART and valacyclovir population coverage. RESULTS: The average duration of HIV infection was 9.5 years. The duration of disease before reaching CD4 200cells/µL was 2.53 years longer for females than males. Relative to a baseline of ART initiation at CD4≤500cells/µL, the valacyclovir scenario resulted in 167,000 fewer HIV infections over ten years, with an incremental cost-effectiveness ratio (ICER) of $5276 per HIV infection averted. A Test and Treat scenario with 70% ART coverage and no valacyclovir resulted in 350,000 fewer HIV infections at an ICER of $2822 and $812 per HIV infection averted and QALY gained, respectively. CONCLUSION: Even when compared with valacyclovir suppression, a drug that reduces HIV viral load, universal treatment for HIV is the optimal strategy for averting new infections and increasing public health benefit. Universal HIV treatment would most effectively and efficiently reduce the HIV burden.

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.

HIV testing of children is not simple for health providers and researchers: Legal and policy frameworks guidance in South Africa.

Antiretroviral treatment coverage for children and adolescents is significantly lower than that for adults. A first step in improving this situation is ensuring increased access to HIV counselling and testing services. Current legal and policy frameworks outline four norms that should inform HIV testing of children in South Africa: limiting HIV testing to defined circumstances, and ensuring that consent is obtained, counselling is provided and confidentiality is maintained. Implementing these norms is not simple. We discuss the challenges and opportunities these norms present for children, their families, health providers and researchers working in this area. Better alignment between evolving public health approaches and the HIV counselling and testing legal/policy frameworks (and the internal coherence of domestic frameworks) would better serve children, their parents and those who work with them.

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.

Mobile VCT: reaching men and young people in urban and rural South African pilot studies (NIMH Project Accept, HPTN 043).

Mounting evidence exists that mobile voluntary counselling and testing (VCT) is able to extend coverage to new localities and populations. We describe two feasibility and acceptability pilot studies conducted in rural and urban South Africa in preparation for the larger NIMH Project Accept HIV prevention trial. A total of 1,015 individuals participated in the pilot studies. Participants in rural Vulindlela were younger (median 22 years) compared to urban Soweto (p < 0.001). Young people were more likely to be first time testers in both sites (p = 0.01 in Vulindlela, p < 0.001 in Soweto), with significantly more men likely to be first time testers than women (p = 0.01 in Vulindlela, p < 0.001 in Soweto). User satisfaction with mobile VCT was extremely high in both sites. Our study shows that providing mobile, high-quality and easy to access services in a high prevalence context is a feasible way to engage youth, men and more rural populations in HIV counselling and testing.

Health diplomacy and the adaptation of global health interventions to local needs in sub-Saharan Africa and Thailand: evaluating findings from Project Accept (HPTN 043).

BACKGROUND: Study-based global health interventions, especially those that are conducted on an international or multi-site basis, frequently require site-specific adaptations in order to (1) respond to socio-cultural differences in risk determinants, (2) to make interventions more relevant to target population needs, and (3) in recognition of 'global health diplomacy' issues. We report on the adaptations development, approval and implementation process from the Project Accept voluntary counseling and testing, community mobilization and post-test support services intervention. METHODS: We reviewed all relevant documentation collected during the study intervention period (e.g. monthly progress reports; bi-annual steering committee presentations) and conducted a series of semi-structured interviews with project directors and between 12 and 23 field staff at each study site in South Africa, Zimbabwe, Thailand and Tanzania during 2009. Respondents were asked to describe (1) the adaptations development and approval process and (2) the most successful site-specific adaptations from the perspective of facilitating intervention implementation. RESULTS: Across sites, proposed adaptations were identified by field staff and submitted to project directors for review on a formally planned basis. The cross-site intervention sub-committee then ensured fidelity to the study protocol before approval. Successfully-implemented adaptations included: intervention delivery adaptations (e.g. development of tailored counseling messages for immigrant labour groups in South Africa) political, environmental and infrastructural adaptations (e.g. use of local community centers as VCT venues in Zimbabwe); religious adaptations (e.g. dividing clients by gender in Muslim areas of Tanzania); economic adaptations (e.g. co-provision of income generating skills classes in Zimbabwe); epidemiological adaptations (e.g. provision of 'youth-friendly' services in South Africa, Zimbabwe and Tanzania), and social adaptations (e.g. modification of terminology to local dialects in Thailand: and adjustment of service delivery schedules to suit seasonal and daily work schedules across sites). CONCLUSIONS: Adaptation selection, development and approval during multi-site global health research studies should be a planned process that maintains fidelity to the study protocol. The successful implementation of appropriate site-specific adaptations may have important implications for intervention implementation, from both a service uptake and a global health diplomacy perspective.

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.