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AbstractIntroductionRoutine viral load monitoring for HIV‐1 management of persons on antiretroviral therapy (ART) has been recommended by the World Health Organization (WHO) to identify treatment failure. However, viral load testing represents a substantial cost in resource constrained health care systems. The central challenge is whether and how viral load monitoring may be delivered such that it maximizes health gains across the population for the costs incurred. We hypothesized that key features of program design and delivery costs drive the cost‐effectiveness of viral load monitoring within programs.MethodsWe conducted a systematic review of studies on the cost‐effectiveness of viral load monitoring in low‐ and middle‐income countries (LMICs). We followed the Cochrane Collaboration guidelines and the PRISMA reporting guidelines.Results and DiscussionWe identified 18 studies that evaluated the cost‐effectiveness of viral load monitoring in HIV treatment programs. Overall, we identified three key factors that make it more likely for viral load monitoring to be cost‐effective: 1) Use of effective, lower cost approaches to viral load monitoring (e.g. use of dried blood spots); 2) Ensuring the pathway to health improvement is established and that viral load results are acted upon; and 3) Viral load results are used to simplify HIV care in patients with viral suppression (i.e. differentiated care, with fewer clinic visits and longer prescriptions). Within the context of differentiated care, viral load monitoring has the potential to double the health gains and be cost saving compared to the current standard (CD4 monitoring).ConclusionsThe cost‐effectiveness of viral load monitoring critically depends on how it is delivered and the program context. Viral load monitoring as part of differentiated HIV care is likely to be cost‐effective. Viral load monitoring in differentiated care programs provides evidence that reduced clinical engagement, where appropriate, is not impacting health outcomes. Introducing viral load monitoring without differentiated care is unlikely to be cost‐effective in most settings and results in lost opportunity for health gains through alternative uses of limited resources. As countries scale up differentiated care programs, data on viral suppression outcomes and costs should be collected to evaluate the on‐going cost‐effectiveness of viral load monitoring as utilized in practice.

AbstractIntroductionModels that project the impact and cost‐effectiveness of HIV pre‐exposure prophylaxis (PrEP) must specify how PrEP use aligns with HIV exposure. We hypothesized that varying PrEP use according to individual‐level partnership dynamics rather than prioritization to population subgroups based on average risk will result in larger incidence reductions and greater efficiency.MethodsWe used an individual‐based network transmission model calibrated to HIV dynamics in Eswatini to simulate PrEP use among individuals ages 15–34 between 2022 and 2031 under two paradigms of PrEP delivery: "Risk Group" and "Partnership." In the "Risk Group" paradigm, we varied PrEP coverage by risk groups (low, medium and high) defined by average partnership frequency and concurrency. In the "Partnership" paradigm, all individuals are potentially eligible for PrEP, but we assumed use occurs only during partnerships and varied prioritization by partner HIV status (no prioritization to high prioritization with HIV‐positive partners). We calculated person‐time on PrEP and incidence relative to a no PrEP scenario and estimated efficiency as the person‐years of PrEP needed to avert one additional infection (NNT).ResultsIn the Risk Group paradigm, restricting PrEP to the high‐risk group was the most efficient (NNT = 17), but the number of infections averted was limited by the small size of the high‐risk group. Expanding PrEP use to all risk groups averted up to three times more infections but with lower efficiency (NNT = 202). PrEP use under the Partnership paradigm was 2–6 times more efficient (NNT = 33–102) than the Risk Group paradigm with all groups eligible for PrEP. A 33% reduction in incidence among 15‐ to 34‐year‐olds was achieved at 46% (95% CI: 39–52%) PrEP coverage in the Risk Group paradigm and 6% (95% CI: 5–7%) to 17% (95% CI: 14–20%) in the Partnership paradigm.ConclusionsModelling PrEP use based on risk groups resulted in a sharp trade‐off between PrEP efficiency and impact, whereas PrEP use predicated on partnerships resulted in much higher efficiency for widespread PrEP availability. Model estimates of PrEP impact and cost‐effectiveness in generalized epidemics are strongly influenced by assumptions about how PrEP use aligns with individual‐level HIV exposure heterogeneity.

To explore the barriers and facilitators of linkage to and retention in care amongst persons who tested positive for HIV, qualitative research was conducted in a home-based HIV counselling and testing (HBCT) project with interventions to facilitate linkages to HIV care in rural KwaZulu-Natal, South Africa. The intervention tested 1,272 adults for HIV in Vulindlela of whom 32% were HIV-positive, received point-of-care (POC) CD4 testing and referral to local HIV clinics. Those testing positive also received follow-up visits from a counsellor to evaluate linkages to care. The study employed a qualitative methodology collecting data through in-depth semi-structured interviews. Respondents included 25 HIV-positive persons who had tested as part of HBCT project, 4 intervention research counsellors who delivered the HBCT intervention and 9 government clinic staff who received referrals for care. The results show that HBCT helped to facilitate linkage to care through providing education and support to help overcome fears of stigma and discrimination. The results show the perceived value of receiving a POC CD4 result during post-test counselling, both for those newly diagnosed and those previously diagnosed as HIV positive. The results also demonstrate that in-depth counselling creates an 'educated consumer' facilitating engagement with clinical services. The study provides qualitative insights into the acceptability of confidential HBCT with same day POC CD4 testing and ART counselling as factors that influenced HIV-positive persons' decisions to link to care. This model warrants further evaluation in non-research settings to determine impact and cost-effectiveness relative to other HIV testing and referral strategies.

AbstractIntroductionPromising HIV vaccine candidates are steadily progressing through the clinical trial pipeline. Once available, HIV vaccines will be an important complement but also potential competitor to other biomedical prevention tools such as pre‐exposure prophylaxis (PrEP). Accordingly, the value of HIV vaccines and the policies for rollout may depend on that interplay and tradeoffs with utilization of existing products. In this economic modelling analysis, we estimate the cost‐effectiveness of HIV vaccines considering their potential interaction with PrEP and condom use.MethodsWe developed a dynamic model of HIV transmission among the men who have sex with men population (MSM), aged 15‐64 years, in Seattle, WA offered PrEP and HIV vaccine over a time horizon of 2025‐2045. A healthcare sector perspective with annual discount rate of 3% for costs (2017 USD) and quality‐adjusted life years (QALYs) was used. The primary economic endpoint is the incremental cost‐effectiveness ratio (ICER) when compared to no HIV vaccine availability.ResultsHIV vaccines improved population health and increased healthcare costs. Vaccination campaigns achieving 90% coverage of high‐risk men and 60% coverage of other men within five years of introduction are projected to avoid 40% of new HIV infections between 2025 and 2045. This increased total healthcare costs by $30 million, with some PrEP costs shifted to HIV vaccine spending. HIV vaccines are estimated to have an ICER of $42,473/QALY, considered cost‐effective using a threshold of $150,000/QALY. Results were most sensitive to HIV vaccine efficacy and future changes in the cost of PrEP drugs. Sensitivity analysis found ranges of 30‐70% HIV vaccine efficacy remained cost‐effective. Results were also sensitive to reductions in condom use among PrEP and vaccine users.ConclusionsAccess to an HIV vaccine is desirable as it could increase the overall effectiveness of combination HIV prevention efforts and improve population health. Planning for the rollout and scale‐up of HIV vaccines should carefully consider the design of policies that guide interactions between vaccine and PrEP utilization and potential competition.

AbstractIntroductionSouth Africa faces epidemics of HIV and non‐communicable diseases (NCDs). The aim of this study was to characterize the prevalence of non‐communicable disease risk factors and depression, stratified by HIV status, in a community with a high burden of HIV.MethodsWe conducted a home‐based HIV counselling and testing study in KwaZulu‐Natal, South Africa between November 2011 and June 2012. Contiguous households were approached and all adults ≥18 years old were offered an HIV test. During follow‐up visits in January 2015, screening for HIV, depression, obesity, blood glucose, cholesterol and blood pressure were conducted using point‐of‐care tests.ResultsOf the 570 participants located and screened; 69% were female and 33% were HIV‐positive. NCD risk factor prevalence was high in this sample; 71% were overweight (body mass index (BMI) 25 to 29.9 kg/m2) or obese (BMI≥30 kg/m2), 4% had hyperglycaemia (plasma glucose >11.0 mmol/l/200 mg/dl), 33% had hypertension (HTN, >140/90 mmHg), 20% had hyperlipidaemia (low density cholesterol >5.2 mmol/l/193.6 mg/dl) and 12% had major depressive symptoms (nine item Patient Health Questionnaire ≥10). Of the 570 participants, 87% had one or more of HIV, hyperglycaemia, HTN, hyperlipidaemia and/or depression. Over half (56%) had two or more. Older age and female gender were significantly associated with the prevalence of both HIV infection and NCD risk factors. Around 80% of both HIV‐positive and negative persons had one of the measured risk factors (i.e. obesity, hyperglycaemia, hyperlipidaemia, HTN), or depression.ConclusionsIn a community‐based sample of adults in KwaZulu‐Natal, South Africa, the prevalence of both HIV infection and NCD risk factors were high. This study is among the first to quantify the substantial burden of NCD risk factors and depression in this non‐clinic based population.

IntroductionHepatitis C virus (HCV) and HIV infection frequently co‐occur due to shared transmission routes. Co‐infection is associated with higher HCV viral load (VL), but less is known about the effect of HCV infection on HIV VL and risk of onward transmission.MethodsWe undertook a systematic review comparing 1) HIV VL among ART‐naïve, HCV co‐infected individuals versus HIV mono‐infected individuals and 2) HIV VL among treated versus untreated HCV co‐infected individuals. We performed a random‐effects meta‐analysis and quantified heterogeneity using the I2 statistic. We followed Cochrane Collaboration guidelines in conducting our review and PRISMA guidelines in reporting results.Results and discussionWe screened 3925 articles and identified 17 relevant publications. A meta‐analysis found no evidence of increased HIV VL associated with HCV co‐infection or between HIV VL and HCV treatment with pegylated interferon‐alpha‐2a/b and ribavirin.ConclusionsThis finding is in contrast to the substantial increases in HIV VL observed with several other systemic infections. It presents opportunities to elucidate the biological pathways that underpin epidemiological synergy in HIV co‐infections and may enable prediction of which co‐infections are most important to epidemic control.

AbstractIntroductionAdolescent girls and young women (AGYW) are a priority population for pre‐exposure prophylaxis (PrEP), a highly effective HIV prevention method. However, effective PrEP use among AGYW has been low. Interventions to support PrEP effective use may improve pill‐taking. Affordability of PrEP programs depends on their cost. We, therefore, evaluated the cost of community‐based PrEP with effective use counselling.MethodsCost data from a randomized controlled trial were used to evaluate the cost of PrEP provision with effective use counselling offered to AGYW through community‐based HIV testing platforms between November 2018 and November 2019. AGYW were randomized to receive (1) group‐based community health club effective use counselling, (2) individualized effective use counselling or (3) community‐based PrEP dispensary. Task shifting of effective use counselling from nurses to trained lay counsellors was implemented in groups 1 and 2. Personnel costs were estimated from time‐and‐motion observations and staff interviews. Expenditure and ingredients‐based approaches were used to estimate costs for medical and non‐medical supplies.ResultsIn total, 603 AGYW initiated PrEP and accrued a total of 1280 months on PrEP. Average cost per person‐month on PrEP with group‐based community health club, individualized effective use counselling and community‐based PrEP dispensary under the Department of Health scenario were similar and high (USD $55.32, $55.65 and $55.46, respectively) due to low PrEP client volume observed in the clinical trial. Increasing client volume (scaled Department of Health scenario) reduced cost per‐person month estimates to USD $15.48, $26.40 and $13.99, respectively.ConclusionsAs designed, individualized effective use counselling increased the cost of standard‐of‐care PrEP delivery by 89%, group‐based community health effective use counselling increased the cost of standard‐of‐care PrEP delivery by 11%. These estimates can inform cost‐effectiveness and budget impact analysis for PrEP provision with effective use counselling services.

AbstractIntroduction: Achieving the UNAIDS goals of 90–90‐90 will require more than doubling the number of people accessing HIV care in Uganda. Community‐based programmes for entry into HIV care are effective strategies to expand access to HIV care, but few programmes have been evaluated with a particular focus on scale‐up.Methods: Integrated Community Based Initiatives, a Uganda‐based non‐governmental organization, designed and implemented a programme of community‐based HIV counselling and testing and facilitated linkage to care utilizing community health extension workers (CHEWs) in rural Sheema District, Uganda. CHEWs performed programme activities during 1 October 2015 through 31 March 2016. Outcomes for this evaluation were (1) the number of people tested for HIV, and (2) the proportion of those testing positive who were seen at an ART clinic within three months of their positive test, and (3) the cost of the programme per person newly diagnosed with HIV. Microcosting methods were used to calculate the programme costs. Program scalability factors were evaluated using a published framework.Results: Sixty‐two CHEWs attended a five‐day training that introduced the biology of HIV, the conduct of confidential HIV testing, HIV prevention messages, and linkage, referral, and reporting requirements. CHEWs received a $30 monthly stipend and a field testing kit that included a bicycle, field bag, umbrella, gumboots, reporting booklet, pens, and HIV testing materials. Trained CHEWs tested 43,696 persons for HIV infection during the six‐month programme period. Nine‐hundred seventy‐four participants (2.2%) were identified as HIV positive, and 623 participants (64%) were linked to HIV care. An estimated 69% of adult residents received testing as part of this campaign. The programme cost $3.02 per person test, $135.70 per positive person identified, and $212.15 per HIV‐positive person linked to care.Conclusions: Lay community health extension workers (CHEWs) can be rapidly trained to scale‐up home‐based HIV testing and counselling (HTC) and linkage to care in a high‐quality and low‐cost manner to large numbers of people in a rural, high burden setting. A combination HIV testing approach, such as adding partner testing to community‐based testing, could increase the proportion of HIV‐positive persons identified.

IntroductionAntiretroviral therapy (ART) prevents HIV transmission within HIV serodiscordant couples (SDCs), but slow implementation and low uptake has limited its impact on population‐level HIV incidence. Home HIV testing and counselling (HTC) campaigns could increase ART uptake among SDCs by incorporating couples' testing and ART referral. We estimated the reduction in adult HIV incidence achieved by incorporating universal ART for SDCs into home HTC campaigns in KwaZulu‐Natal (KZN), South Africa, and southwestern (SW) Uganda.MethodsWe constructed dynamic, stochastic, agent‐based network models for each region. We compared adult HIV incidence after 10 years under three scenarios: (1) "Current Practice," (2) "Home HTC" with linkage to ART for eligible persons (CD4 <350) and (3) "ART for SDCs" regardless of CD4, delivered alongside home HTC.ResultsART for SDCs reduced HIV incidence by 38% versus Home HTC: from 1.12 (95% CI: 0.98–1.26) to 0.68 (0.54–0.82) cases per 100 person‐years (py) in KZN, and from 0.56 (0.50–0.62) to 0.35 (0.30–0.39) cases per 100 py in SW Uganda. A quarter of incident HIV infections were averted over 10 years, and the proportion of virally suppressed HIV‐positive persons increased approximately 15%.ConclusionsUsing home HTC to identify SDCs and deliver universal ART could avert substantially more new HIV infections than home HTC alone, with a smaller number needed to treat to prevent new HIV infections. Scale‐up of home HTC will not diminish the effectiveness of targeting SDCs for treatment. Increasing rates of couples' testing, disclosure, and linkage to care is an efficient way to increase the impact of home HTC interventions on HIV incidence.

IntroductionDespite scale‐up of antiretroviral therapy (ART) for treating HIV‐positive persons, HIV incidence remains elevated among those at high risk such as persons in serodiscordant partnerships. Antiretrovirals taken by HIV‐negative persons as pre‐exposure prophylaxis (PrEP) has the potential to avert infections in individuals in serodiscordant partnerships. Evaluating the cost‐effectiveness of implementing time‐limited PrEP as a short‐term bridge during the first six months of ART for the HIV‐positive partner to prevent HIV transmission compared to increasing ART coverage is crucial to informing policy‐makers considering PrEP implementation.MethodsTo estimate the real world delivery costs of PrEP, we conducted micro‐costing and time and motion analyses in an open‐label prospective study of PrEP and ART delivery targeted to high‐risk serodiscordant couples in Uganda (the Partners Demonstration Project). The cost (in USD, in 2012) of PrEP and ART for serodiscordant couples was assessed, with and without research components, in the study setting. Using Ministry of Health costs, the cost of PrEP and ART provision within a government programme was estimated, as was the cost of providing PrEP in addition to ART. We parameterized an HIV transmission model to estimate the health and economic impacts of 1) PrEP and ART targeted to high‐risk serodiscordant couples in the context of current ART use and 2) increasing ART coverage to 55% of HIV‐positive persons with CD4 ≤500 cells/µL without PrEP. The incremental cost‐effectiveness ratios (ICERs) per HIV infection and disability‐adjusted life year (DALY) averted were calculated over 10 years.ResultsThe annual cost of PrEP and ART delivery for serodiscordant couples was $1058 per couple in the study setting and $453 in the government setting. The portion of the programme cost due to PrEP was $408 and $92 per couple per year in the study and government settings, respectively. Over 10 years, a programme of PrEP and ART for high‐risk serodiscordant couples was projected to avert 43% of HIV infections compared to current practice with an ICER of $1340 per infection averted. This was comparable to ART expansion alone, which would avert 37% of infections with an ICER of $1452.ConclusionsUsing Uganda's gross domestic product per capita of $1681 as a threshold, PrEP and ART for high‐risk persons have the potential for synergistic action and are cost‐effective in preventing HIV infections in high prevalence settings. The annual cost of PrEP in this programme is less than $100 per serodiscordant couple if implemented in public clinics.

IntroductionThe 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.MethodsWe 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.ResultsTrial 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.ConclusionsHome 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.

AbstractIntroductionIn settings with high HIV prevalence, cervical cancer incidence rates are up to six‐fold higher than the global average of 13.1 cases per 100,000 women‐years. To inform strategies for global cervical cancer elimination, we used a dynamic transmission model to evaluate scalable screening and treatment strategies, accounting for HIV‐associated cancer risks and weighing prevention gains against overtreatment.MethodsWe developed a dynamic model of HIV‐HPV co‐infection and disease progression, which we calibrated to KwaZulu‐Natal, South Africa. Our baseline scenario reflects the current practice of HPV vaccination with a multi‐visit screening and treatment strategy involving cytology and colposcopy triage. We evaluated 13 comparator scenarios with increased vaccination coverage and one‐time, two‐time or repeat HIV‐targeted cervical cancer screening with the following single‐visit strategies: HPV DNA testing, HPV genotyping, automated visual evaluation (AVE) and HPV DNA with AVE triage. In all scenarios, HIV antiretroviral therapy, condom use and voluntary male medical circumcision continue at baseline levels. We simulated cancer incidence under each scenario from 2020 to 2120 using the 25 best‐fitting parameter sets. We present the median and range of model output from these simulations to account for parameter uncertainty.ResultsWe estimate that cervical cancer incidence will decrease by 87% with the continuation of current cervical cancer and HIV prevention strategies, from an age‐standardized rate per 100,000 women of 80.4 (range 58.2, 112.1) in 2020 to 10.7 (4.2, 29.9) in 2120. Scenarios scaling up vaccination and single‐visit strategies resulted in near‐ and long‐term gains. With repeat HIV‐targeted screening, incidence rates were projected to be 29–34% lower in 2030 relative to the baseline scenario, and elimination (incidence <4/100,000) was achieved with HPV DNA testing in 2095 and with AVE in 2114. A strategy of HPV DNA with AVE triage optimized the tradeoff between cancer cases averted and overtreatment.ConclusionsSingle‐visit screening strategies could avert a substantial burden of cervical cancer and accelerate progress towards elimination in settings with a high burden of HIV. Increasing the screening frequency among women with HIV and reducing loss‐to‐follow‐up for treatment will be key components of a successful elimination strategy.

AbstractIntimate partners play an important role in chronic diseases. Despite the chronic disease burden in sub‐Saharan Africa, very few culturally relevant quantitative measures of intimate relationship functioning are available. We conducted an empirical investigation evaluating the psychometric properties of the South African Relationship Functioning Assessment (SARFA) assessing healthy relationship functioning in N = 150 community members (50% women; M age = 27.2 years) living in the Vulindlela area of KwaZulu‐Natal, South Africa. Item development was based on prior qualitative research from two South African communities. All assessments were conducted in isiZulu, participants' primary language. An exploratory factor analysis was conducted on the initial 39‐item measure. The best‐fitting model consisted of one factor with 22 items. The SARFA's internal consistency was α = .94. Convergent validity was observed via significant positive associations (all rs ≥ .38, p < .001) between the SARFA's total score and measures of trust, emotional intimacy, constructive communication, sexual satisfaction, and relationship control (women only). Divergent validity was observed for women only. Encouraging initial psychometric properties of a culturally relevant measure of relationship functioning in KwaZulu‐Natal may have relevance to other communities and potential to be used in research involving couples and health in chronic disease‐burdened communities.

AbstractIntroductionAdolescent girls and young women (AGYW) in Africa have high HIV incidence despite scale‐up of HIV testing and HIV treatment. Placebo‐controlled trials of tenofovir‐based pre‐exposure prophylaxi (PrEP) in diverse populations demonstrated that PrEP works with close to 100% effectiveness if taken with high, but not perfect, adherence. Divergent efficacy estimates among African AGYW led to demonstration and implementation projects to better understand motivations for HIV prevention, uptake, adherence and persistence to PrEP. To inform PrEP programmes, the design and initial findings from PrEP demonstration projects for AGYW are reviewed.DiscussionEarly lessons from PrEP implementation projects among young African women include: (1) awareness and demand creation with positive messaging about the benefits of PrEP are critical to motivate AGYW to consider this novel prevention technology and to foster awareness among peers, partners, parents and guardians to support AGYW's effective PrEP use; (2) PrEP initiation is high in projects that are integrating PrEP into youth‐friendly clinics, family planning clinics and mobile clinics; (3) young African women at risk are initiating PrEP, based on behavioural characteristics, history of intimate partner violence, depression and 30% prevalence of chlamydia and/or gonorrhoea; (4) provision of youth‐friendly PrEP delivery programmes that integrate reproductive health services, including contraception and the diagnosis and treatment of sexually transmitted infections, increase health impact; (5) messages that emphasize the necessity for high adherence while at potential risk of HIV exposure and support strategies that addresses AGYW's adherence challenges are essential; and, (6) a substantial proportion of AGYW do not persist with PrEP, and strategies are needed to help AGYW assess their ongoing need, motivation and challenges with persisting with PrEP.ConclusionsPrEP is feasible to implement in integrated reproductive health service delivery models to reach African AGYW. While PrEP demonstration projects indicate that women with behavioural risks and high rates of sexually transmitted diseases are initiating PrEP; effective strategies to support AGYW's adherence and persistence with PrEP are needed. Lessons learned from oral PrEP delivery, a novel first generation HIV prevention product, are relevant to longer‐acting and less adherence‐dependent strategies which are currently in clinical trials.