Provider and female client economic costs of integrated sexual and reproductive health and HIV services in Zimbabwe.

A retrospective facility-based costing study was undertaken to estimate the comparative cost per visit of five integrated sexual and reproductive health and HIV (human immuno-deficiency virus) services (provider perspective) within five clinic sites. These five clinics were part of four service delivery models: Non-governmental-organisation (NGO) directly managed model (Chitungwiza and New Africa House sites), NGO partner managed site (Mutare site), private-public-partnership (PPP) model (Chitungwiza Profam Clinic), and NGO directly managed outreach (operating from New Africa House site. In addition client cost exit interviews (client perspective) were conducted among 856 female clients exiting integrated services at three of the sites. Our costing approach involved first a facility bottom-up costing exercise (February to April 2015), conducted to quantify and value each resource input required to provide individual SRH and HIV services. Secondly overhead financial expenditures were allocated top-down from central office to sites and then respective integrated service based on pre-defined allocation factors derived from both the site facility observations and programme data for the prior 12 months. Costs were assessed in 2015 United States dollars (USD). Costs were assessed for HIV testing and counselling, screening and treatment of sexually transmitted infections, tuberculosis screening with smear microscopy, family planning, and cervical cancer screening and treatment employing visual inspection with acetic acid and cervicography and cryotherapy. Variability in costs per visit was evident across the models being highest for cervical cancer screening and cryotherapy (range: US$6.98-US$49.66). HIV testing and counselling showed least variability (range; US$10.96-US$16.28). In general the PPP model offered integrated services at the lowest unit costs whereas the partner managed site was highest. Significant client costs remain despite availability of integrated sexual and reproductive health and HIV services free of charge in our Zimbabwe study setting. Situating services closer to communities, incentives, transport reimbursements, reducing waiting times and co-location of sexual and reproductive health and HIV services may help minimise impact of client costs.

Do community measures impact the effectiveness of a community led HIV testing intervention. Secondary analysis of an HIV self-testing intervention in rural communities in Zimbabwe.

BACKGROUND: There is a growing body of evidence for the role that communities can have in producing beneficial health outcomes. There is also an increasing recognition of the effectiveness and success of community-led interventions to promote public health efforts. This study investigated whether and how community-level measures facilitate a community-led intervention to achieve improved HIV outcomes. METHODS: This is a secondary analysis of survey data from a cluster randomised trial in 40 rural communities in Zimbabwe. The survey was conducted four months after the intervention was initiated. Communities were randomised 1:1 to either paid distribution arm, where HIV self-test (HIVST) kits were distributed by a paid distributor, or community-led whereby members of the community were responsible for organising and conducting the distribution of HIVST kits. We used mixed effects logistic regression to assess the effect of social cohesion, problem solving, and HIV awareness on HIV testing and prevention. RESULTS: We found no association between community measures and the three HIV outcomes (self-testing, new HIV diagnosis and linkage to VMMC or confirmatory testing). However, the interaction analyses highlighted that in high social cohesion communities, the odds of new HIV diagnosis was greater in the community-led arm than paid distribution arm (OR 2.06 95% CI 1.03-4.19). CONCLUSION: We found some evidence that community-led interventions reached more undiagnosed people living with HIV in places with high social cohesion. Additional research should seek to understand whether the effect of social cohesion is persistent across other community interventions and outcomes. TRIAL REGISTRATION: PACTR201607001701788.

Preferences for oral-fluid-based or blood-based HIV self-testing and provider-delivered testing: an observational study among different populations in Zimbabwe.

BACKGROUND: There is limited data on client preferences for different HIV self-testing (HIVST) and provider-delivered testing options and associated factors. We explored client preferences for oral-fluid-based self-testing (OFBST), blood-based self-testing (BBST) and provider-delivered blood-based testing (PDBBT) among different populations. METHODS: At clinics providing HIV testing services to general populations (1 urban, 1 rural clinic), men seeking voluntary medical male circumcision (VMMC, 1 clinic), and female sex workers (FSW, 1 clinic), clients had the option to test using OFBST, BBST or PDBBT. A pre-test questionnaire collected information on demographics and testing history. Two weeks after collecting a self-test kit, participants responded to a questionnaire. We used logistic regression to determine predictors of choices. We also conducted 20 in-depth interviews to contextualise quantitative findings. RESULTS: May to June 2019, we recruited 1244 participants of whom 249 (20%), 251 (20%), 244 (20%) and 500 (40%) were attending urban general, rural, VMMC and FSW clinics, respectively. Half (n = 619, 50%) chose OFBST, 440 (35%) and 185 (15%) chose BBST and PDBBT, respectively. In multivariable analysis comparing those choosing HIVST (OFBST and BBST combined) versus not, those who had never married aOR 0.57 (95% CI 0.34-0.93) and those previously married aOR0.56 (0.34-0.93) were less likely versus married participants to choose HIVST. HIVST preference increased with education, aOR 2.00 (1.28-3.13), 2.55 (1.28-5.07), 2.76 (1.48-5.14) for ordinary, advanced and tertiary education, respectively versus none/primary education. HIVST preference decreased with age aOR 0.97 (0.96-0.99). Urban participants were more likely than rural ones to choose HIVST, aOR 9.77 (5.47-17.41), 3.38 (2.03-5.62) and 2.23 (1.38-3.61) for FSW, urban general and VMMC clients, respectively. Comparing those choosing OFBST with those choosing BBST, less literate participants were less likely to choose oral fluid tests, aOR 0.29 (0.09-0.92). CONCLUSIONS: Most testing clients opted for OFBST, followed by BBST and lastly, PDBBT. Those who self-assessed as less healthy were more likely to opt for PDBBT which likely facilitated linkage. Results show importance of continued provision of all strategies in order to meet needs of different populations, and may be useful to inform both HIVST kit stock projections and tailoring of HIVST programs to meet the needs of different populations.

Potential cost-effectiveness of community availability of tenofovir, lamivudine, and dolutegravir for HIV prevention and treatment in east, central, southern, and west Africa: a modelling analysis.

BACKGROUND: Post-exposure prophylaxis (PEP) offers protection from HIV after condomless sex, but is not widely available in a timely manner in east, central, southern, and west Africa. To inform the potential pilot implementation of such an approach, we modelled the effect and cost-effectiveness of making PEP consisting of tenofovir, lamivudine, and dolutegravir (TLD) freely and locally available in communities without prescription, with the aim of enabling PEP use within 24 h of condomless sex. Free community availability of TLD (referred to as community TLD) might also result in some use of TLD as pre-exposure prophylaxis (PrEP) and as antiretroviral therapy for people living with HIV. METHODS: Using an existing individual-based model (HIV Synthesis), we explicitly modelled the potential positive and negative effects of community TLD. Through the sampling of parameter values we created 1000 setting-scenarios, reflecting the uncertainty in assumptions and a range of settings similar to those seen in east, central, southern, and west Africa (with a median HIV prevalence of 14·8% in women and 8·1% in men). For each setting scenario, we considered the effects of community TLD. TLD PEP was assumed to have at least 90% efficacy in preventing HIV infection after condomless sex with a person living with HIV. FINDINGS: The modelled effects of community TLD availability based on an assumed high uptake of TLD resulted in a mean reduction in incidence of 31% (90% range over setting scenarios, 6% increase to 57% decrease) over 20 years, with an HIV incidence reduction over 50 years in 91% of the 1000 setting scenarios, deaths averted in 55% of scenarios, reduction in costs in 92% of scenarios, and disability-adjusted life-years averted in 64% of scenarios with community TLD. Community TLD was cost-effective in 90% of setting scenarios and cost-saving (with disability-adjusted life-years averted) in 58% of scenarios. When only examining setting scenarios in which there was lower uptake of community TLD, community TLD is cost-effective in 92% of setting scenarios. INTERPRETATION: The introduction of community TLD, enabling greater PEP access, is a promising approach to consider further in pilot implementation projects. FUNDING: Bill & Melinda Gates Foundation to the HIV Modelling Consortium.

COVID-19 self-testing using antigen rapid diagnostic tests: Feasibility evaluation among health-care workers and general population in Malawi.

BACKGROUND: COVID-19 testing is critical for identifying cases to prevent transmission. COVID-19 self-testing has the potential to increase diagnostic testing capacity and to expand access to hard-to-reach areas in low-and-middle-income countries. We investigated the feasibility and acceptability of COVID-19 self-sampling and self-testing using SARS-CoV-2 Antigen-Rapid Diagnostic Tests (Ag-RDTs). METHODS: From July 2021 to February 2022, we conducted a mixed-methods cross-sectional study examining self-sampling and self-testing using Standard Q and Panbio COVID-19 Ag Rapid Test Device in Urban and rural Blantyre, Malawi. Health care workers and adults (18y+) in the general population were non-randomly sampled. RESULTS: Overall, 1,330 participants were enrolled of whom 674 (56.0%) were female and 656 (54.0%) were male with 664 for self-sampling and 666 for self-testing. Mean age was 30.7y (standard deviation [SD] 9.6). Self-sampling usability threshold for Standard Q was 273/333 (82.0%: 95% CI 77.4% to 86.0%) and 261/331 (78.8%: 95% CI 74.1% to 83.1%) for Panbio. Self-testing threshold was 276/335 (82.4%: 95% CI 77.9% to 86.3%) and 300/332 (90.4%: 95% CI 86.7% to 93.3%) for Standard Q and Panbio, respectively. Agreement between self-sample results and professional test results was 325/325 (100%) and 322/322 (100%) for Standard Q and Panbio, respectively. For self-testing, agreement was 332/333 (99.7%: 95% CI 98.3 to 100%) for Standard Q and 330/330 (100%: 95% CI 99.8 to 100%) for Panbio. Odds of achieving self-sampling threshold increased if the participant was recruited from an urban site (odds ratio [OR] 2.15 95% CI 1.44 to 3.23, P < .01. Compared to participants with primary school education those with secondary and tertiary achieved higher self-testing threshold OR 1.88 (95% CI 1.17 to 3.01), P = .01 and 4.05 (95% CI 1.20 to13.63), P = .02, respectively. CONCLUSIONS: One of the first studies to demonstrate high feasibility and acceptability of self-testing using SARS-CoV-2 Ag-RDTs among general and health-care worker populations in low- and middle-income countries potentially supporting large scale-up. Further research is warranted to provide optimal delivery strategies of self-testing.

Did you hear about HIV self-testing? HIV self-testing awareness after community-based HIVST distribution in rural Zimbabwe.

BACKGROUND: Several trials of community-based HIV self-testing (HIVST) provide evidence on the acceptability and feasibility of campaign-style distribution to reach first-time testers, men and adolescents. However, we do not know how many remain unaware of HIVST after distribution campaigns, and who these individuals are. Here we look at factors associated with never having heard of HIVST after community-based campaign-style HIVST distribution in rural Zimbabwe between September 2016 and July 2017. METHODS: Analysis of representative population-based trial survey data collected from 7146 individuals following community-based HIVST distribution to households was conducted. Factors associated with having never heard of HIVST were determined using multivariable mixed-effects logistic regression adjusted for clustered design. RESULTS: Among survey participants, 1308 (18.3%) self-reported having never heard of HIVST. Individuals who were between 20 and 60 years old {20-29 years: [aOR = 0.74, 95% CI (0.58-0.95)], 30-39 years: [aOR = 0.56, 95% CI (0.42-0.74)], 40-49 years: [aOR = 0.50, 95% CI (0.36-0.68)], 50-59 years [aOR = 0.58, 95% CI (0.42-0.82)]}, who had attained at least ordinary level education [aOR = 0.51, 95% CI (0.34-0.76)], and who had an HIV test before [aOR = 0.30, 95% CI (0.25-0.37)] were less likely to have never heard of HIVST compared with individuals who were between 16 and 19 years old, who had a lower educational level and who had never tested for HIV before, respectively. In addition, non-household heads or household head representatives [aOR = 1.21, 95% CI (1.01-1.45)] were more likely to report never having heard of HIVST compared to household head and representatives. CONCLUSIONS: Around one fifth of survey participants remain unaware of HIVST even after an intensive community-based door-to-door HIVST distribution. Of note, those least likely to have heard of self-testing were younger, less educated and less likely to have tested previously. Household heads appear to play an important role in granting or denying access to self-testing to other household members during door-to-door distribution. Differentiated distribution models are needed to ensure access to all. Trial registration PACTR, PACTR201607001701788. Registered 29 June 2016, https://pactr.samrc.ac.za/ PACTR201607001701788.

Community-based HIV self-testing: a cluster-randomised trial of supply-side financial incentives and time-trend analysis of linkage to antiretroviral therapy in Zimbabwe.

BACKGROUND: HIV self-testing (HIVST) requires linkage to post-test services to maximise its benefits. We evaluated effect of supply-side incentivisation on linkage following community-based HIVST and evaluated time-trends in facility-based antiretroviral therapy (ART) initiations. METHODS: From August 2016 to August 2017 community-based distributors (CBDs) in 38 rural Zimbabwean communities distributed HIVST door-to-door in 19-25 day campaigns. Communities were allocated (1:1) using constrained randomisation to either one-off US$50 remuneration per CBD (non-incentive arm), or US$50 plus US$0.20 incentive per client visiting mobile-outreach services (conditional-incentive arm). The primary outcome, assessed by population survey 6 weeks later, was self-reported uptake of any clinic service, analysed with random-effects logistic regression. Separately, non-randomised difference-in-differences in monthly ART initiations were analysed for three time periods (6 months baseline; HIVST campaign; 3 months after) at public clinics with (40 clinics) and without (124 clinics) HIVST distribution in catchment area. FINDINGS: A total of 445 conditional-incentive CBDs distributed 39 205 HIVST kits (mean/CBD: 88; 95% CI: 85 to 92) and 447 non-incentive CBDs distributed 41 173 kits (mean/CBD: 93; 95% CI: 89 to 96). Survey participation was 7146/8566 (83.4%), with 3593 (50.3%) reporting self-testing including 1305 (18.3%) previously untested individuals. Use of clinic services post-HIVST was similar in conditional-incentive (1062/3698, 28.7%) and non-incentive (1075/3448, 31.2%) arms (adjusted risk ratio (aRR) 0.94, 95% CI: 0.86 to 1.03). Confirmatory testing by newly diagnosed/untreated HIVST+clients was, however, higher (conditional-incentive: 25/33, 75.8% vs non-incentive: 20/40, 50.0%: aRR: 1.59, 95% CI: 1.05 to 2.39). In total, 12 808 ART initiations occurred, with no baseline or postcampaign differences between initiation rates in HIVST versus non-HIVST clinics, but initiation rates increased from 7.31 to 9.59 initiations per month in HIVST clinics during distribution, aRR: 1.27, 95% CI 1.17 to 1.39. CONCLUSIONS: Community-based HIVST campaigns achieved high testing uptake, temporally associated with increased demand for ART. Small supply-side incentives did not affect general clinic usage but may have increased confirmatory testing for newly diagnosed HIVST positive participants. TRIAL REGISTRATION NUMBER: PACTR201607001701788.

ART initiations following community-based distribution of HIV self-tests: meta-analysis and meta-regression of STAR Initiative data.

INTRODUCTION: Measuring linkage after community-based testing, particularly HIV self-testing (HIVST), is challenging. Here, we use data from studies of community-based HIVST distribution, conducted within the STAR Initiative, to assess initiation of antiretroviral therapy (ART) and factors driving differences in linkage rates. METHODS: Five STAR studies evaluated HIVST implementation in Malawi, Zambia and Zimbabwe. New ART initiations during the months of intervention at clinics in HIVST and comparison areas were presented graphically, and study effects combined using meta-analysis. Meta-regression was used to estimate associations between the impact of community-based HIVST distribution and indicators of implementation context, intensity and reach. Effect size estimates used (1) prespecified trial definitions of ART timing and comparator facilities and (2) exploratory definitions accounting for unexpected diffusion of HIVST into comparison areas and periods with less distribution of HIVST than was expected. RESULTS: Compared with arms with standard testing only, ART initiations were higher in clinics in HIVST distribution areas in 4/5 studies. The prespecified meta-analysis found positive but variable effects of HIVST on facility ART initiations (RR: 1.14, 95% CI 0.93 to 1.40; p=0.21). The exploratory meta-analysis found a stronger impact of HIVST distribution on ART initiations (RR: 1.29, 95% CI 1.08 to 1.55, p=0.02).ART initiations were higher in studies with greater self-reported population-level intensity of HIVST use (RR: 1.12; 95% CI 1.04 to 1.21; p=0.02.), but did not differ by national-level indicators of ART use among people living with HIV, number of HIVST kits distributed per 1000 population, or self-reported knowledge of how to link to care after a reactive HIVST. CONCLUSION: Community-based HIVST distribution has variable effect on ART initiations compared with standard testing service alone. Optimising both support for and approach to measurement of effective and timely linkage or relinkage to HIV care and prevention following HIVST is needed to maximise impact and guide implementation strategies.

Comparison of community-led distribution of HIV self-tests kits with distribution by paid distributors: a cluster randomised trial in rural Zimbabwean communities.

BACKGROUND: We compared community-led versus an established community-based HIV self-testing (HIVST) model in rural Zimbabwe using a cluster-randomised trial. METHODS: Forty village groups were randomised 1:1 using restricted randomisation to community-led HIVST, where communities planned and implemented HIVST distribution for 4 weeks, or paid distribution (PD), where distributors were paid US$50 to distribute kits door-to-door over 4 weeks. Individual level primary outcomes compared household survey responses by arm 4 months post-intervention for: (1) newly diagnosed HIV during/within 4 months following HIVST distribution, (2) linkage to confirmatory testing, pre-exposure prophylaxis or voluntary medical male circumcision during/within 4 months following HIVST distribution. Participants were not masked to allocation; analysis used masked data. Trial analysis used random-effects logistic regression.Distribution costs compared: (1) community-led HIVST, (2) PD HIVST and (3) PD costs when first implemented in 2016/2017. RESULTS: From October 2018 to August 2019, 27 812 and 36 699 HIVST kits were distributed in community-led and PD communities, respectively. We surveyed 11 150 participants and 5683 were in community-led arm. New HIV diagnosis was reported by 211 (3.7%) community-led versus 197 (3.6%) PD arm participants, adjusted OR (aOR) 1.1 (95% CI 0.72 to 1.56); 318 (25.9%) community-led arm participants linked to post-test services versus 361 (23.9%) in PD arm, aOR 1.1 (95% CI 0.75 to 1.49.Cost per HIVST kit distributed was US$6.29 and US$10.25 for PD and community-led HIVST, both lower than 2016/2017 costs for newly implemented PD (US$14.52). No social harms were reported. CONCLUSIONS: Community-led HIVST can perform as well as paid distribution, with lower costs in the first year. These costs may reduce with programme maturity/learning. TRIAL REGISTRATION NUMBER: PACTR201811849455568.

Costs of integrating HIV self-testing in public health facilities in Malawi, South Africa, Zambia and Zimbabwe.

INTRODUCTION: As countries approach the UNAIDS 95-95-95 targets, there is a need for innovative and cost-saving HIV testing approaches that can increase testing coverage in hard-to-reach populations. The HIV Self-Testing Africa-Initiative distributed HIV self-test (HIVST) kits using unincentivised HIV testing counsellors across 31 public facilities in Malawi, South Africa, Zambia and Zimbabwe. HIVST was distributed either through secondary (partner's use) distribution alone or primary (own use) and secondary distribution approaches. METHODS: We evaluated the costs of adding HIVST to existing HIV testing from the providers' perspective in the 31 public health facilities across the four countries between 2018 and 2019. We combined expenditure analysis and bottom-up costing approaches. We also carried out time-and-motion studies on the counsellors to estimate the human resource costs of introducing and demonstrating how to use HIVST for primary and secondary use. RESULTS: A total of 41 720 kits were distributed during the analysis period, ranging from 1254 in Zimbabwe to 27 678 in Zambia. The cost per kit distributed through the primary distribution approach was $4.27 in Zambia and $9.24 in Zimbabwe. The cost per kit distributed through the secondary distribution approach ranged from $6.46 in Zambia to $13.42 in South Africa, with a wider variation in the average cost at facility-level. From the time-and-motion observations, the counsellors spent between 20% and 44% of the observed workday on HIVST. Overall, personnel and test kit costs were the main cost drivers. CONCLUSION: The average costs of distributing HIVST kits were comparable across the four countries in our analysis despite wide cost variability within countries. We recommend context-specific exploration of potential efficiency gains from these facility-level cost variations and demand creation activities to ensure continued affordability at scale.

Values and preferences of contraceptive methods: a mixed-methods study among sex workers from diverse settings.

There is limited information on contraceptive values and preferences of sex workers. We conducted a mixed-method study to explore contraceptive values and preferences among sex workers. We conducted an online survey with individuals from 38 countries (n = 239), 6 focus group discussions (FGD, n = 68) in Zimbabwe, and 12 in-depth phone interviews (IDI) across 4 world regions, in June and July of 2019. Participants were asked about awareness of contraceptives, methods they had used in the past, and the determinants of their choices. Differences between respondents from high-, low- and middle- income countries were examined. Qualitative data were analysed thematically. Survey participants reported an awareness of modern contraceptive methods. FGDs found that younger women had lower awareness. Reports of condomless sex were common and modern contraceptive use was inconsistent. Determinants of contraceptive choices differed by setting according to results of the survey, FGD, and IDI. Regardless of country income level, determinants of contraceptive choices included ease of use, ease of access to a contraceptive method, and fewer side effects. Healthcare provider attitudes, availability of methods, and clinic schedules were important considerations. Most sex workers are aware of contraceptives, but barriers include male partners/clients, side effects, and health system factors such as access and clinic attitudes towards sex workers.

A Landscape Analysis of Offering HIV Testing Services Within Family Planning Service Delivery.

Introduction: Offering HIV testing services (HTS) within sexual and reproductive health (SRH) services is a priority, especially for women who have a substantial risk. To reach women with HIV who do not know their status and prevent mother-to-child HIV transmission, the World Health Organization (WHO) recommends routinely offering HTS as part of family planning (FP) service delivery in high HIV burden settings. We conducted a landscape analysis to assess HTS uptake and HIV positivity in the context of FP/SRH services. Assessment of Research and Programs: We searched records from PubMed, four gray literature databases, and 13 organization websites, and emailed 24 organizations for data on HTS in FP/SRH services. We also obtained data from International Planned Parenthood Federation (IPPF) affiliates in Eswatini, Kenya, Lesotho, Malawi, Namibia, Uganda, Zambia, and Zimbabwe. Unique programs/studies from records were included if they provided data on, or barriers/facilitators to, offering HTS in FP/SRH. Overall, 2,197 records were screened and 12 unique programs/studies were eligible, including 10 from sub-Saharan Africa. Four reported on co-delivery of SRH services (including FP), with reported HTS uptake between 17 and 94%. Six reported data on HTS in FP services: four among general FP clients; one among couples; and one among female sex workers, adolescent girls, and young women. Two of the six reported HTS uptake >50% (51%, 419/814 Kenya; 63%, 5,930/9,439 Uganda), with positivity rates of 2% and 4.1%, respectively. Uptake was low (8%, 74/969 Kenya) in the one FP program offering pre-exposure prophylaxis. In the IPPF program, seven countries reported HTS uptake in FP services and ranged from 4% in Eswatini to 90% in Lesotho; between 0.6% (Uganda) and 8% (Eswatini) of those tested were HIV positive. Implications: Data on providing HTS in FP/SRH service delivery were sparse and HTS uptake varied widely across programs. Actionable Recommendations: As countries expand HTS in FP/SRH appropriate to epidemiology, they should ensure data are reported and monitored for progress and impact.