Satisfaction with service delivery among HIV treatment clients enrolled in differentiated and conventional models of care in South Africa: a baseline survey.

INTRODUCTION: Differentiated service delivery (DSD) models aim to increase the responsiveness of HIV treatment programmes to the individual needs of antiretroviral therapy (ART) clients to improve treatment outcomes and quality of life. Little is known about how DSD client experiences differ from conventional care. METHODS: From May to November 2021, we interviewed adult (≥18) ART clients at 21 primary clinics in four districts of South Africa. Participants were enrolled consecutively at routine visits and stratified into four groups: conventional care-not eligible for DSD (conventional-not-eligible); conventional care eligible for but not enrolled in DSD (conventional-not-enrolled); facility pickup point DSD model; and external pickup point DSD model. Satisfaction was assessed using questions with 5-point Likert-scale responses. Mean scores were categorized as not satisfied (score ≤3) or satisfied (>3). We used logistic regression to assess differences and report crude and adjusted odds ratios (aORs). Qualitative themes were identified through content analysis. RESULTS: Eight hundred and sixty-seven participants (70% female, median age 39) were surveyed: 24% facility pick-up points; 27% external pick-up points; 25% conventional-not-eligible; and 24% conventional-not-enrolled. Seventy-four percent of all study participants expressed satisfaction with their HIV care. Those enrolled in DSD models were more likely to be satisfied, with an aOR of 6.24 (95% CI [3.18-12.24]) for external pick-up point versus conventional-not-eligible and an aOR of 3.30 (1.95-5.58) for facility pick-up point versus conventional-not-eligible. Conventional-not-enrolled clients were slightly but not significantly more satisfied than conventional-not-eligible clients (1.29, 0.85-1.96). Those seeking outside healthcare (crude OR 0.57, 0.41-0.81) or reporting more annual clinic visits (0.52, 0.29-0.93) were less likely to be satisfied. Conventional care participants reporting satisfaction with their current model of care perceived providers as helpful, respectful, and friendly and were satisfied with care despite long queues. DSD model participants emphasized ease and convenience, particularly not having to queue. CONCLUSIONS: Most adult ART clients in South Africa were satisfied with their care, but those enrolled in DSD models expressed slightly greater satisfaction than those remaining in conventional care. Efforts should focus on enrolling more eligible patients into DSD models, expanding eligibility criteria to cover a wider client base, and further improving the models' desirable characteristics.

Thetha Nami ngithethe nawe (Let's Talk): a stepped-wedge cluster randomised trial of social mobilisation by peer navigators into community-based sexual health and HIV care, including pre-exposure prophylaxis (PrEP), to reduce sexually transmissible HIV amongst young people in rural KwaZulu-Natal, South Africa.

BACKGROUND: Antiretroviral therapy (ART) through universal test and treat (UTT) and HIV pre-exposure prophylaxis (PrEP) substantially reduces HIV-related mortality and incidence. Effective ART based prevention has not translated into population-level impact in southern Africa due to sub-optimal coverage among youth. We aim to investigate the effectiveness, implementation and cost effectiveness of peer-led social mobilisation into decentralised integrated HIV and sexual reproductive health (SRH) services amongst adolescents and young adults in KwaZulu-Natal (KZN). METHODS: We are conducting a type 1a hybrid effectiveness/implementation study, with a cluster randomized stepped-wedge trial (SWT) to assess effectiveness and a realist process evaluation to assess implementation outcomes. The SWT will be conducted in 40 clusters in rural KZN over 45 months. Clusters will be randomly allocated to receive the intervention in period 1 (early) or period 2 (delayed). 1) Intervention arm: Resident peer navigators in each cluster will approach young men and women aged 15-30 years living in their cluster to conduct health, social and educational needs assessment and tailor psychosocial support and health promotion, peer mentorship, and facilitate referrals into nurse led mobile clinics that visit each cluster regularly to deliver integrated SRH and differentiated HIV prevention (HIV testing, UTT for those positive, and PrEP for those eligible and negative). Standard of Care is UTT and PrEP delivered to 15-30 year olds from control clusters through primary health clinics. There are 3 co-primary outcomes measured amongst cross sectional surveys of 15-30 year olds: 1) effectiveness of the intervention in reducing the prevalence of sexually transmissible HIV; 2) uptake of universal risk informed HIV prevention intervention; 3) cost of transmissible HIV infection averted. We will use a realist process evaluation to interrogate the extent to which the intervention components support demand, uptake, and retention in risk-differentiated biomedical HIV prevention. DISCUSSION: The findings of this trial will be used by policy makers to optimize delivery of universal differentiated HIV prevention, including HIV pre-exposure prophylaxis through peer-led mobilisation into community-based integrated adolescent and youth friendly HIV and sexual and reproductive health care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier-NCT05405582. Registered: 6th June 2022.

Costs and outcomes of routine HIV oral pre-exposure prophylaxis implementation across different service delivery models and key populations in South Africa.

Background: Oral pre-exposure prophylaxis (PrEP) is a highly efficacious biomedical HIV prevention tool, yet despite being recommended by the World Health Organization (WHO) since 2015, uptake and persistence remain limited in much of the world, including sub Saharan Africa (SSA). There is a dearth of evidence-based interventions to improve PrEP uptake and persistence in SSA, and the full costs of PrEP programs implemented in routine care settings remain largely unknown. This study aimed to evaluate the cost of delivery of daily oral PrEP, and associated outcomes, to different key and priority populations across different service delivery models (SDMs) in South Africa. Methods: We conducted bottom-up micro-costing of PrEP service delivery from the provider perspective within twelve urban SDMs providing routine PrEP services to various key and propriety populations in Gauteng and KwaZulu-Natal provinces in South Africa. The SDMs included in-facility and outreach models that focused on men who have sex with men (MSM), female sex workers (FSW) and adolescent girls and young women (AGYW). We identified all within- and above-facility activities supporting PrEP delivery, obtained input costs from program budgets, expenditure records and staff interviews, and determined individual resource usage between February 2019 and February 2020 through retrospective medical record review. Our primary outcome was PrEP coverage at six months (defined as having sufficient PrEP drug dispensed at the last visit to be covered at six months post PrEP-initiation). A subset (N=633) of all enrolled subjects had the potential for 12 months of follow-up and were included in a 12-month outcome analysis. We report the cost per client initiated on PrEP in 2021 United States Dollars (USD). Findings: We collected medical record data from 1,281 people who initiated PrEP at 12 SDMs between February and August 2019 and had at least six months of potential follow-up. The average number of visits was 2.3 for in-facility models and 1.5 for outreach models and 3,086 months of PrEP was dispensed. PrEP coverage at six months varied greatly across SDMs, from 41.8% at one MSM-focused fixed clinic to 0% in an MSM-focused outreach model. In general, in-facility programs had higher six-month coverage than outreach programs. Across all SDMs with PrEP clients with potential for 12 months of follow-up (n=633), PrEP coverage at 12 months was 13.6%, with variability between SDMs. The average six-month cost per client initiated on PrEP ranged from $29 to $590, with higher average costs generally observed for the in-facility programs ($152 in-facility versus $84 for outreach). The average monthly cost per PrEP client who had six-month PrEP coverage ranged from $18 to $160 dependent on SDM. Interpretation: This study is an important addition to the PrEP outcome and cost literature in the SSA region. Results show that costs and outcomes vary considerably across different SDMs and populations in real world PrEP programs and provide crucial information for further scale-up of the oral PrEP program in South Africa and the greater SSA region.

The early-stage comprehensive costs of routine PrEP implementation and scale-up in Zambia.

Pre-exposure prophylaxis (PrEP) is an effective HIV prevention option, but cost-effectiveness is sensitive to implementation and program costs. Studies indicate that, in addition to direct delivery cost, PrEP provision requires substantial demand creation and client support to encourage PrEP initiation and persistence. We estimated the cost of providing PrEP in Zambia through different PrEP delivery models. Taking a guidelines-based approach for visits, labs and drugs, we estimated the annual cost of providing PrEP per client for five delivery models: one focused on key populations (men-who-have-sex-with-men (MSM) and female sex workers (FSW), one on adolescent girls and young women (AGYW), and three integrated programs (operated within HIV counselling and testing services at primary healthcare centres). Program start-up and support costs were based on program expenditure data and number of PrEP sites and clients in 2018. PrEP clinic visit costs were based on micro-costing at two PrEP delivery sites (2018 USD). Costs are presented in 2018 prices and inflated to 2021 prices. The annual cost/PrEP client varied by service delivery model, from $394 (AGYW) to $655 (integrated model). Cost differences were driven largely by client volume, which impacted the relative costs of program support and technical assistance assigned to each PrEP client. Direct service delivery costs ranged narrowly from $205-212/PrEP-client and were a key component in the cost of PrEP, representing 35-65% of total costs. The results show that, even when integrated into full service delivery models, accessing vulnerable, marginalised populations at substantial risk of HIV infection is likely to cost more than previously estimated due to the programmatic costs involved in community sensitization and client support. Improved data on individual client resource usage and outcomes is required to get a better understanding of the true resource utilization, expected outcomes and annual costs of different PrEP service delivery programs in Zambia.

Initial implementation of PrEP in Zambia: health policy development and service delivery scale-up.

INTRODUCTION: Daily pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but not yet widely deployed in sub-Saharan Africa. We describe how Zambia developed PrEP health policy and then successfully implemented national PrEP service delivery. POLICY DEVELOPMENT: Zambia introduced PrEP as a key strategy for HIV prevention in 2016, and established a National PrEP Task Force to lead policy advocacy and development. The Task Force was composed of government representatives, regulatory agencies, international donors, implementation partners and civil society organisations. Following an implementation pilot, PrEP was rolled out nationally using risk-based criteria alongside a national HIV prevention campaign. NATIONAL SCALE-UP: In the first year of implementation, ending September 2018, 3626 persons initiated PrEP. By September 2019, the number of people starting PrEP increased by over sixfold to 23 327 persons at 728 sites across all ten Zambian provinces. In the first 2 years, 26 953 clients initiated PrEP in Zambia, of whom 31% were from key and priority populations. Continuation remains low at 25% and 11% at 6 and 12 months, respectively. LESSONS LEARNT: Risk-based criteria for PrEP ensures access to those most in need of HIV prevention. Healthcare worker training in PrEP service delivery and health needs of key and priority populations is crucial. PrEP expansion into primary healthcare clinics and community education is required to reach full potential. Additional work is needed to understand and address low PrEP continuation. Finally, a task force of key stakeholders can rapidly develop and implement health policy, which may serve as a model for countries seeking to implement PrEP.

Attrition in HIV care following HIV diagnosis: a comparison of the pre-UTT and UTT eras in South Africa.

INTRODUCTION: Policies for Universal Test & Treat (UTT) and same-day initiation (SDI) of antiretroviral therapy (ART) were instituted in South Africa in September 2016 and 2017 respectively. However, there is limited evidence on whether these changes have improved patient retention after HIV diagnosis. METHODS: We enrolled three cohorts of newly diagnosed HIV-infected adults from two primary health clinics in Johannesburg from April to November 2015 (Pre-UTT, N = 144), May-September 2017 (UTT, N = 178) and October-December 2017 (SDI, N = 88). A baseline survey was administered immediately after HIV diagnosis after which follow-up using clinical records (paper charts, electronic health records and laboratory data) ensued for 12 months. The primary outcome was patient loss to follow-up (being >90 days late for the last scheduled appointment) at 12 months post-HIV diagnosis. We modelled attrition across HIV policy periods with Cox proportional hazard regression. RESULTS: Overall, 410 of 580 screened HIV-positive patients were enrolled. Overall, attrition at 12 months was 30% lower in the UTT guideline period (38.2%) compared to pre-UTT (47.2%, aHR 0.7, 95% CI: 0.5 to 1.0). However, the total attrition was similar between the SDI (47.7%) and pre-UTT cohorts (aHR 1.0, 95% CI: 0.7 to 1.5). Older age at HIV diagnosis (aHR 0.5 for ≥40 vs. 25 to 29 years, 95% CI: 0.3 to 0.8) and being in a non-marital relationship (aHR 0.5 vs. being single, 95% CI: 0.3 to 0.8) protected against LTFU at 12 months, whereas LTFU rates increased with longer travel time to the diagnosing clinic (aHR 1.8 for ≥30 minutes vs. ≤15 minutes, 95% CI: 1.1 to 3.1). In analyses adjusted for the time-varying ART initiation status, compared to the pre-ART period of care, the hazard of on-ART LTFU was 90% higher among participants diagnosed under the SDI policy compared to pre-UTT (aHR 1.9, 95% CI: 1.1 to 2.9). CONCLUSIONS: Overall, nearly two-fifths of HIV positive patients are likely to disengage from care by 12 months after HIV diagnosis under the new SDI policy. Furthermore, the increase in on-ART patient attrition after the introduction of the SDI policy is cause for concern. Further research is needed to determine the best way for rapidly initiating patients on ART and also reducing long-term attrition from care.

Impact of the test and treat policy on delays in antiretroviral therapy initiation among adult HIV positive patients from six clinics in Johannesburg, South Africa: results from a prospective cohort study.

OBJECTIVES: To assess delays to antiretroviral therapy (ART) initiation before and after the Universal Test and Treat (UTT) and the same-day initiation (SDI) of ART policy periods in Johannesburg, South Africa. DESIGN: Prospective cohort study. SETTING: Patients were recruited from six primary health clinics in Johannesburg. PARTICIPANTS: Overall, 1029 newly diagnosed HIV positive adults (≥18 years) were consecutively enrolled by referral from the testing counsellor between April and December 2015 (pre-UTT n=146), July and August 2017 (UTT, n=141) and October 2017 and August 2018 (SDI, n=742). MAIN OUTCOME MEASURES: Cox proportional hazards regression was used to assess predictors of 30 days ART initiation. Additionally, predictors of immediate ART initiation were evaluated using Poisson regression. RESULTS: Overall, 30 days ART proportions were 71.9% overall, 36.9% pre-UTT (44.3% of those eligible), 65.9% under UTT and 79.9% under the SDI policy. The median days to ART initiation declined from 21 pre-UTT (IQR: 15-30) to 8 (IQR: 6-16) under UTT and 5 days (IQR: 0-8) under the SDI policy. However, only 150 (20.2%) of the SDI cohort-initiated ART immediately after HIV diagnosis. Living in a two-adult home (adjusted HR (aHR) 1.2 vs living alone, 95% CI 1.0 to 1.5) increased the likelihood of 30-day ART. Missing baseline cluster of differentiation four (CD4) data decreased the likelihood of 30 days ART by 40% (aHR 0.6 vs CD4 <350 cells/µL, 95% CI 0.5 to 0.7). More women took up immediate ART (adjusted relative risk (aRR) 1.3, 95% CI 1.0 to 1.9). Participants ≥40 years (aRR 0.6 vs 18-24 years, 95% CI 0.4 to 0.9) were less likely to start ART immediately after HIV diagnosis. However, immediate ART rates increased with longer policy implementation time (aRR 0.2 for <3 months vs >10 months, 95% CI 0.1 to 0.4). CONCLUSIONS: The study results highlight a positive move towards earlier ART initiation during the UTT and SDI periods and emphasise a need to increase same-day ART implementation further.

HIV Treatment Outcomes Among Patients Initiated on Antiretroviral Therapy Pre and Post-Universal Test and Treat Guidelines in South Africa.

INTRODUCTION: Officially rolled out on 01 September 2016, South Africa's Universal Test and Treat (UTT) policy calls for first-line antiretroviral treatment (ART) initiation among all known HIV-positive patients, irrespective of CD4 cell count. We evaluate treatment outcomes of patients initiated on first-line ART directly before and after the implementation of UTT. METHODS: We analysed prospectively collected clinical cohort data among ART-naïve adult patients within two HIV clinics in Johannesburg, South Africa. We compare two groups: 1) an unexposed pre-UTT group initiating treatment from 01 December 2014 to 31 May 2015; and 2) an exposed UTT group initiating treatment from 01 December 2016 to 31 May 2017. Primary treatment outcomes included lost to follow-up (LTFU) (>90 days late for the last scheduled visit with no subsequent clinical visit). Cox proportional hazards models were used to estimate the association between pre-UTT vs UTT initiation on LTFU by 12 months. RESULTS: We included 2410 patients. A total of 1267 (52.6%) patients initiated ART before UTT implementation and 1143 (47.4%) after the change in policy. LTFU (adjusted Hazard Ratio (aHR): 1.51; 95% Confidence Interval (CI): 1.16-1.98) between groups and specifically among those initiating with a CD4 cell count ≤500 cells/mm3 (aHR: 1.59; 95% CI: 1.21-2.10) was higher among patients initiating ART under UTT. CONCLUSION: LTFU under UTT proved higher than that of previous periods. Patients initiating first-line therapy under the treat-all policy may often start treatment in better health, subsequently not perceiving a direct benefit to treatment which may deter patients from consistent engagement in HIV treatment programmes.

Provider perspectives on contraceptive service delivery: findings from a qualitative study in Johannesburg, South Africa.

BACKGROUND: Healthcare providers' skills and attitudes are both barriers and facilitators of contraceptive uptake. In South Africa, migration of healthcare workers and the demands of the HIV epidemic have also contributed to inequitable access to sexual and reproductive health (SRH) care. Yet, the country has committed to achieving universal access to SRH services. We explored healthcare provider's opinions and attitudes on provision of contraceptive services in public facilities, their personal use of methods, and their thoughts on the recent integration of new contraceptive methods in their facilities. METHODS: We conducted a phenomenological, qualitative study in 2017 at an outpatient, public HIV treatment clinic and two primary healthcare clinics (PHCs) in Johannesburg, South Africa. We purposively selected providers who had worked at the facilities for at least six months and were seeing patients for HIV or SRH services. Trained study staff conducted semi-structured interviews. We conducted descriptive analyses for quantitative data, and used an iterative, thematic analysis approach for open-ended responses. RESULTS: We interviewed 14 healthcare providers (HIV clinic - 5; PHCs - 9). One respondent was a man; all were nurses. All respondents reported having ever personally used a contraceptive method; half (7/14) were currently using a method. Responses on service provision were conflicting. Respondents felt that their clinics currently met the contraceptive needs of their female patients through on-site services or referrals. However, they noted that staff shortages, lack of training, and a limited contraceptive offering meant that women did not always get the counselling or method they wanted. Respondents noted that the 'best' contraceptive methods for women were those that fit with a woman's lifestyle and medical needs; however, providers also felt strongly that injectables were best for all women. Recent introduction of the implant at one PHC and injectable contraceptives at the HIV clinic was not overly challenging, though there were concerns about staffing and demand creation for the new methods. CONCLUSIONS: Respondents' conflicting responses revealed challenges with current service delivery, particularly contraceptive counselling. Addressing staff workloads and providing refresher training on contraception would contribute to increased contraceptive service capacity and quality in this setting.

Novel metric for evaluating pre-exposure prophylaxis programme effectiveness in real-world settings.

Although large-scale provision of HIV pre-exposure prophylaxis (PrEP) is gaining momentum, no systematic method to evaluate or compare the effectiveness of different scale-up strategies in real-world settings exists. To date, estimating the effectiveness of PrEP has relied on clinical trials or mathematical models. We propose a novel and pragmatic metric to evaluate and compare programme effectiveness using routine implementation data. Using South African and Zambian PrEP guidelines, we provide two examples of how to consistently measure PrEP-programme effectiveness with routinely collected data. PrEP effectiveness should account for HIV seroconversion, the variable risk of HIV infection (seasons of risk) estimated with routine risk assessment at each clinic visit (when available), and the persistence of PrEP use. Three criteria should be met in order to be considered a successful outcome: first, a person who initiates PrEP must not seroconvert; second, there should be no more than one period at high risk of HIV infection during the follow-up period when not taking PrEP; and finally, an individual must continue to attend health-care visits or discontinue prophylaxis in consultation with a health-care provider within a specified follow-up period. The number of PrEP successes could then be compared with the total number of people initiating PrEP to establish a success ratio. This outcome is a useful and easily interpretable metric to monitor effectiveness of PrEP programmes with routinely collected clinical data and can be used in cost-effectiveness analyses. These measurements allow for comparisons of scale-up strategies for PrEP programmes and, if widely adopted, will allow comparative studies of different approaches for PrEP service delivery.

Women's costs for accessing comprehensive sexual and reproductive health services: findings from an observational study in Johannesburg, South Africa.

BACKGROUND: Evaluating progress towards the Sustainable Development Goal of universal access to sexual and reproductive (SRH) services requires an understanding of the health needs of individuals and what constitutes access to services. We explored women's costs of accessing SRH services in Johannesburg, South Africa and contextualized costs based on estimates of household income. METHODS: We conducted an observational study of women aged 18-49 at a public HIV treatment site and two public primary health care facilities from June 2015 to August 2016. Interviews assessed women's SRH needs (for contraception, fertility problems, menstrual problems, menopause symptoms, sexually transmitted infections (STI), experiences of intimate-partner violence (IPV), and cervical and breast cancer screening) and associated costs. We calculated average and total costs (including out-of-pocket spending, lost income, and estimated value of time spent) for women who incurred costs. We also estimated the total and average costs of meeting all SRH needs in a hypothetical "full needs met" year. Finally, we contextualize SRH spending against a measure of catastrophic expenditure (> 10% of household income). RESULTS: Among the 385 women who participated, 94.8% had at least one SRH need in the prior 12 months; 79.7% incurred costs for accessing care. On average, women spent $28.34 on SRH needs during the prior year. Excluding one HIV-negative woman who spent 112% of her annual income on infertility treatment, HIV-positive women spent more on average annually for SRH care than HIV-negative women. Sixty percent of women reported at least one unmet SRH need. If all participants sought care for all reported needs, their average annual cost would rise to $52.65 per woman. Only two women reported catastrophic expenditure - for managing infertility. CONCLUSIONS: SRH needs are constants throughout women's lives. Small annual costs can become large costs when considered cumulatively over time. As South Africa and other countries grapple with increasing access to SRH services under the rubric of universal access, it is important to remember that individuals incur costs despite free care at the point of service. Policies that address geographic proximity and service quality would be important for reducing costs and ensuring full access to SRH services. Literature on women's financial and economic costs for accessing comprehensive sexual and reproductive health care in low- and middle-income countries is extremely limited, and existing literature often overlooks out-of-pocket costs associated with travel, child care, and time spent accessing services. Using data from a survey of 385 women from a public HIV treatment site and two public primary health care facilities in Johannesburg, we found nearly all women reported at least on sexual and reproductive health need and more than 75% of women incurred costs related to those needs. Furthermore, more than half of women surveyed reported not accessing services for their sexual and reproductive health needs, suggesting a total annual cost of more than $50 USD, on average, to access services for all reported needs. While few women spent more than 10% of their total household income on sexual and reproductive health services in the prior year, needs are constant and costs incur throughout a woman's life suggesting accessing services to meet these needs might still result in financial burden. As South Africa grapples with increasing access to sexual and reproductive health services under the rubric of universal access, it is important to remember that individuals incur costs despite free care at the point of service. Policies that address geographic proximity and service quality would be important for reducing costs and ensuring full access to services.

Epidemiological impact and cost-effectiveness of providing long-acting pre-exposure prophylaxis to injectable contraceptive users for HIV prevention in South Africa: a modelling study.

INTRODUCTION: Although pre-exposure prophylaxis (PrEP.) is an efficacious HIV prevention strategy, its preventive benefit has not been shown among young women in sub-Saharan Africa, likely due to non-adherence. Adherence may be improved with the use of injectable long-acting PrEP methods currently being developed. We hypothesize that providing long-acting PrEP to women using injectable contraceptives, the most frequently used contraceptive method in South Africa, could improve adherence to PrEP, result in a reduction of new HIV infections, and be a relatively easy-to-reach target population. In this modelling study, we assessed the epidemiological impact and cost-effectiveness of providing long-acting PrEP to injectable contraceptive users in Limpopo, South Africa. METHODS: We developed a deterministic mathematical model calibrated to the HIV epidemic in Limpopo. Long-acting PrEP was provided to 50% of HIV negative injectable contraceptive users in 2018 and scaled-up over two years. We estimated the number of HIV infections that could be averted by 2030 and the drug price of long-acting PrEP for which this intervention would be cost-effective over a time horizon of 40 years, from a healthcare payer perspective. In the base-case scenario we assumed long-acting PrEP is 75% effective in preventing HIV infections and 85% of infected individuals are on antiretroviral drug therapy (ART) by 2030. In sensitivity analyses we adjusted PrEP effectiveness and ART coverage. Costs between $519 and $1119 per disability-adjusted life-year (DALY) averted were considered potentially cost-effective, and <$519 as cost-effective. RESULTS: Without long-acting injectable PrEP, 224,000 (interquartile range 176,000 to 271,000) new infections will occur by 2030; use of long-acting injectable PrEP could prevent 21,000 (17,000 to 26,000) or 9.8% (8.9% to 10.6%) new HIV infections by 2030 (including 6000 (4000 to 7000) in men). Long-acting PrEP would prevent 34,000 (29,000 to 39,000) or 12,000 (8000 to 15,000) at 75% and 95% ART coverage by 2030 respectively. To be considered potentially cost-effective the annual long-acting PrEP drug price should be <$16, and/or ART coverage remains at <85% in 2030. CONCLUSIONS: Providing long-acting PrEP to injectable contraceptive users in Limpopo is only potentially cost-effective when long-acting PrEP drug prices are low. If low prices are not feasible, providing long-acting PrEP only to women at high risk of HIV infection will become important.

"My future is bright I won't die with the cause of AIDS": ten-year patient ART outcomes and experiences in South Africa.

INTRODUCTION: South Africa is moving into a new era of HIV treatment with "treat all" policies where people may be on treatment for most of their lives. We need to understand treatment outcomes and facilitators of long-term antiretroviral treatment (ART) adherence and retention-in-care in the South African context. In one of the first studies to investigate long-term treatment outcomes in South Africa, we aimed to describe ten-year patient outcomes at a large public-sector HIV clinic in Johannesburg and explore patient experiences of the treatment programme over this time in order to ascertain factors that may aid or hinder long-term adherence and retention. METHODS: We conducted a cohort analysis (n = 6644) and in-depth interviews (n = 24) among HIV-positive adults initiating first-line ART between April 2004 and March 2007. Using clinical records, we ascertained twelve-month and ten-year all-cause mortality and loss to follow-up (LTF). Cox proportional hazards regression was used to identify baseline predictors of attrition (mortality and LTF (>3 months late for the last scheduled visit)) at twelve months and ten years. Twenty-four patients were purposively selected and interviewed to explore treatment programme experiences over ten years on ART. RESULTS: Excluding transfers, 79.5% (95% confidence intervals (CI): 78.5 to 80.5) of the cohort were alive, in care at twelve months dropping to 35.1% (95% CI: 33.7 to 36.4) at ten years. Over 44% of deaths occurred within 12 months. Ten-year all-cause mortality increased, while LTF decreased slightly, with age. Year and age at ART initiation, sex, nationality, baseline CD4 count, anaemia, body mass index and initiating regimen were predictors of ten-year attrition. Among patients interviewed, the pretreatment clinic environment, feelings of gratitude and good fortune, support networks, and self-efficacy were facilitators of care; side effects, travel and worsening clinical conditions were barriers. Participants were generally optimistic about their futures and were committed to continued care. CONCLUSIONS: This study demonstrates the complexities of long-term chronic HIV treatment with declining all-cause mortality and increasing LTF over ten years. Barriers to long-term retention still present a significant challenge. As more people become eligible for ART in South Africa under "treatment for all," new healthcare delivery challenges will arise; interventions are needed to ensure long-term programme successes continue.

Characterizing breast conditions at an open-access breast clinic in South Africa: a model that is more than cancer care for a resource-limited setting.

BACKGROUND: While most breast-related research focuses on cancer, presentation of symptomatic persons in non-screened environments requires understanding the spectrum of breast diseases so as to plan services in resource-constrained settings. This study presents the variety of breast disease managed at a government, open-access breast clinic in South Africa. METHODS: We performed a retrospective file review using a systematic random sample of patients 18 years and above presenting for breast care over a 14-month period. We collected demographics, clinical characteristics, management and final diagnoses from the first visit and twelve subsequent months. RESULTS: The final sample contained 365 individuals (97 · 5% women). Most were black, unmarried and South African citizens with a median age of 43 years (IQR 31-55) . Of those reporting their status (24 · 1%) 38 · 6% were HIV-positive. A mass (57 · 0%) and/or pain (28 · 5%) were the most common symptoms. Imaging and breast biopsies were required in 78 and 25% of individuals, respectively. Nearly half of biopsies identified breast cancer (44 · 1% of women ≤40 and 57 · 3% for women >40). Benign conditions (47 · 7%) and no abnormality (18 · 2%) were common final classifications among women. There was no difference between the final classifications of patients who self-referred versus those who were formally referred from another health care provider. Nearly half of the participants (46 · 6%) travelled 20 km or more to attend the clinic. CONCLUSIONS: Benign breast conditions far outweighed cancer diagnoses. As breast cancer awareness increases in resource-limited countries, facilities offering breast care require administrative and clinical preparation to manage a range of non-cancer related conditions.

Imputing HIV treatment start dates from routine laboratory data in South Africa: a validation study.

BACKGROUND: Poor clinical record keeping hinders health systems monitoring and patient care in many low resource settings. We develop and validate a novel method to impute dates of antiretroviral treatment (ART) initiation from routine laboratory data in South Africa's public sector HIV program. This method will enable monitoring of the national ART program using real-time laboratory data, avoiding the error potential of chart review. METHODS: We developed an algorithm to impute ART start dates based on the date of a patient's "ART workup", i.e. the laboratory tests used to determine treatment readiness in national guidelines, and the time from ART workup to initiation based on clinical protocols (21 days). To validate the algorithm, we analyzed data from two large clinical HIV cohorts: Hlabisa HIV Treatment and Care Programme in rural KwaZulu-Natal; and Right to Care Cohort in urban Gauteng. Both cohorts contain known ART initiation dates and laboratory results imported directly from the National Health Laboratory Service. We assessed median time from ART workup to ART initiation and calculated sensitivity (SE), specificity (SP), positive predictive value (PPV), and negative predictive value (NPV) of our imputed start date vs. the true start date within a 6 month window. Heterogeneity was assessed across individual clinics and over time. RESULTS: We analyzed data from over 80,000 HIV-positive adults. Among patients who had a workup and initiated ART, median time to initiation was 16 days (IQR 7,31) in Hlabisa and 21 (IQR 8,43) in RTC cohort. Among patients with known ART start dates, SE of the imputed start date was 83% in Hlabisa and 88% in RTC, indicating this method accurately predicts ART start dates for about 85% of all ART initiators. In Hlabisa, PPV was 95%, indicating that for patients with a lab workup, true start dates were predicted with high accuracy. SP (100%) and NPV (92%) were also very high. CONCLUSIONS: Routine laboratory data can be used to infer ART initiation dates in South Africa's public sector. Where care is provided based on protocols, laboratory data can be used to monitor health systems performance and improve accuracy and completeness of clinical records.

Client-pharmacy worker interactions regarding medical abortion in Zambia in 2009 and 2011.

OBJECTIVE: To examine sales practices, knowledge, and behavior of pharmacy workers regarding medical abortion in 2009 and 2011 in Zambia, where hostile and stigmatizing attitudes still result in high rates of unsafe abortion. METHODS: Four mystery clients visited pharmacies during 2009 and 2011, and recorded their experiences following their interactions using a standardized form. Bivariate analysis examined pharmacy workers' attitudes, behavior, and medical abortion-dispensing practices. RESULTS: Mystery clients visited 76 pharmacies in 2009 and 80 pharmacies in 2011. In 2011, mystery clients reported hostile interactions with pharmacy workers at 8 (10%) pharmacy visits, a relative decrease from 7 (22%) in 2009 (P=0.0353). In 2009, less than half (35 [46%]) of clients received information or had the opportunity to purchase medical abortion drugs in comparison with 53 (66%) in 2011 (P=0.0110). In 2011, more pharmacy workers mentioned a valid medical abortion drug in comparison with 2009 (42 [53%] vs 31 [41%], respectively); however, guidance for women on misoprostol use was minimal. CONCLUSION: Pharmacy workers exhibited increased awareness of misoprostol, less hostility, and a willingness to sell medical abortion drugs; however, they continued to provide inadequate information on misoprostol for medical abortion. Effective training of pharmacy employees is vital in increasing access to safe induced-abortion care.