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BACKGROUND: Key populations (KP), including men who have sex with men (MSM), female sex workers (FSW), and transgender women (TGW), experience a disproportionate burden of HIV, even in generalized epidemics like South Africa. Given this disproportionate burden and unique barriers to accessing health services, sustained provision of care is particularly relevant. It is unclear how the COVID-19 pandemic and its associated restrictions may have impacted this delivery. In this study, we aimed to describe patterns of engagement in HIV prevention and treatment services among KP in South Africa and assess the impact of different COVID-19 restriction levels on service delivery. METHODS: We leveraged programmatic data collected by the US President's Emergency Plan for AIDS Relief (PEPFAR)-supported KP partners in South Africa. We divided data into three discrete time periods based on national COVID-19 restriction periods: (i) Pre-restriction period, (ii) High-level restriction period, and (iii) After-high level restriction period. Primary outcomes included monthly total HIV tests, new HIV cases identified, new initiations of pre-exposure prophylaxis (PrEP), and new enrollments in antiretroviral therapy (ART). We conducted interrupted time series segmented regression analyses to estimate the impact of COVID-19 restrictions on HIV prevention and treatment service utilization. RESULTS: Between January 2018 and June 2022, there were a total of 231,086 HIV tests, 27,051 HIV positive cases, 27,656 pre-exposure prophylaxis (PrEP) initiations, and 15,949 antiretroviral therapy initiations among MSM, FSW and TGW in PEPFAR-supported KP programs in South Africa. We recorded 90,457 total HIV tests during the 'pre-restriction' period, with 13,593 confirmed new HIV diagnoses; 26,134 total HIV tests with 2,771 new diagnoses during the 'high-level restriction' period; and 114,495 HIV tests with 10,687 new diagnoses during the after high-level restriction period. Our Poisson regression model estimates indicate an immediate and significant decrease in service engagement at the onset of COVID-19 restrictions, including declines in HIV testing, treatment, and PrEP use, which persisted. As programs adjusted to the new restrictions, there was a gradual rebound in service engagement, particularly among MSM and FSW. Towards the end of the high-level restriction period, with some aspects of daily life returning to normal but others still restricted, there was more variability. Some indicators continued to improve, while others stagnated or decreased. CONCLUSION: Service provision rebounded from the initial shock created by pandemic-related restrictions, and HIV services were largely maintained for KP in South Africa. These results suggest that HIV service delivery among programs designed for KP was able to be flexible and resilient to the evolving restrictions. The results of this study can inform plans for future pandemics and large-scale disruptions to the delivery of HIV services.

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In early 2022, as the vaccination rate in South Africa slowed, there was a strong need for COVID-19 communications to evolve from mass information and education campaigns targeting the general population, to more targeted approaches to motivate uptake amongst population segments facing convenience, complacency, and confidence barriers.Project Last Mile (PLM) and Ipsos conducted a representative study of the population of South Africa to: (1) understand population segments with regards to their likelihood of getting the COVID-19 vaccine, (2) understand the drivers and barriers around getting the COVID-19 vaccine for each segment; and (3) test the likelihood of adoption of a range of enabling, incentivizing, and mandating behavioral interventions ("nudges and shoves").The study demonstrated that a significant proportion of the unvaccinated population is willing to get vaccinated, given the right conditions. Making it easy and convenient to get vaccinated (enabling) is likely to deliver moderate to strong impact. Ease of access, the ability to take time off from work, the provision of a reservation, and free transportation were the most influential factors in encouraging vaccination for the largest number of people.

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INTRODUCTION: Voluntary medical male circumcision (VMMC) clients are required to attend multiple post-operative follow-up visits in South Africa. However, with demonstrated VMMC safety, stretched clinic staff in SA may conduct more than 400,000 unnecessary reviews for males without complications, annually. Embedded into a randomized controlled trial (RCT) to test safety of two-way, text-based (2wT) follow-up as compared to routine in-person visits among adult clients, the objective of this study was to compare 2wT and routine post-VMMC care costs in rural and urban South African settings. METHODS: Activity-based costing (ABC) estimated the costs of post-VMMC care, including counselling, follow-ups, and tracing in $US dollars. Transportation for VMMC and follow-up was provided for rural clients in outreach settings but not for urban clients in static sites. Data were collected from National Department of Health VMMC forms, RCT databases, and time-and-motion surveys. Sensitivity analysis presents different follow-up scenarios. We hypothesized that 2wT would save per-client costs overall, with higher savings in rural settings. RESULTS: VMMC program costs were estimated from 1,084 RCT clients: 537 in routine care and 547 in 2wT. On average, 2wT saved $3.56 per client as compared to routine care. By location, 2wT saved $7.73 per rural client and increased urban costs by $0.59 per client. 2wT would save $2.16 and $7.02 in follow-up program costs if men attended one or two post-VMMC visits, respectively. CONCLUSION: Quality 2wT follow-up care reduces overall post-VMMC care costs by supporting most men to heal at home while triaging clients with potential complications to timely, in-person care. 2wT saves more in rural areas where 2wT offsets transportation costs. Minimal additional 2wT costs in urban areas reflect high care quality and client engagement, a worthy investment for improved VMMC service delivery. 2wT scale-up in South Africa could significantly reduce overall VMMC costs while maintaining service quality.

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Background: Voluntary medical male circumcision (MC) is a biomedical HIV prevention method that requires post-operative follow-up for healing confirmation. Recent research found that a two-way texting (2wT) app providing SMS-based telehealth for MC patients was safe and reduced provider workload. We evaluated 2wT usability among MC clients in South Africa assigned the 2wT intervention within a larger randomized controlled trial (RCT) of 2wT safety and workload. Methods: This quantitative usability study is within an RCT where 547 men used 2wT to interact with an MC provider via SMS. The sub-study involved the first 100 men assigned to 2wT who completed a usability survey 14 days after surgery. Acceptability was assessed through 2wT response rates of the 547 men. Regression models analyzed associations between age, wage, location, potential adverse events (AEs), and 2wT responses. Results: Men assigned to 2wT found it safe, comfortable, and convenient, reporting time and cost savings. High response rates (88%) to daily messages indicated acceptability. Age, wage, and location didn't affect text responses or potential AEs. Conclusion: 2wT for post-MC follow-up was highly usable and acceptable, suggesting its viability as an alternative to in-person visits. It enhanced confidence in wound self-management. This SMS-based telehealth can enhance MC care quality and be adapted to similar contexts for independent healing support, particularly for men.

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BACKGROUND: There is a dearth of high-quality evidence from digital health interventions in routine program settings in low- and middle-income countries. We previously conducted a randomized controlled trial (RCT) in Zimbabwe, demonstrating that 2-way texting (2wT) was safe and effective for follow-up after adult voluntary medical male circumcision (VMMC). OBJECTIVE: To demonstrate the replicability of 2wT, we conducted a larger RCT in both urban and rural VMMC settings in South Africa to determine whether 2wT improves adverse event (AE) ascertainment and, therefore, the quality of follow-up after VMMC while reducing health care workers' workload. METHODS: A prospective, unblinded, noninferiority RCT was conducted among adult participants who underwent VMMC with cell phones randomized in a 1:1 ratio between 2wT and control (routine care) in North West and Gauteng provinces. The 2wT participants responded to a daily SMS text message with in-person follow-up only if desired or an AE was suspected. The control group was requested to make in-person visits on postoperative days 2 and 7 as per national VMMC guidelines. All participants were asked to return on postoperative day 14 for study-specific review. Safety (cumulative AEs ≤day 14 visit) and workload (number of in-person follow-up visits) were compared. Differences in cumulative AEs were calculated between groups. Noninferiority was prespecified with a margin of -0.25%. The Manning score method was used to calculate 95% CIs. RESULTS: The study was conducted between June 7, 2021, and February 21, 2022. In total, 1084 men were enrolled (2wT: n=547, 50.5%, control: n=537, 49.5%), with near-equal proportions of rural and urban participants. Cumulative AEs were identified in 2.3% (95% CI 1.3-4.1) of 2wT participants and 1.0% (95% CI 0.4-2.3) of control participants, demonstrating noninferiority (1-sided 95% CI -0.09 to ∞). Among the 2wT participants, 11 AEs (9 moderate and 2 severe) were identified, compared with 5 AEs (all moderate) among the control participants-a nonsignificant difference in AE rates (P=.13). The 2wT participants attended 0.22 visits, and the control participants attended 1.34 visits-a significant reduction in follow-up visit workload (P<.001). The 2wT approach reduced unnecessary postoperative visits by 84.8%. Daily response rates ranged from 86% on day 3 to 74% on day 13. Among the 2wT participants, 94% (514/547) responded to ≥1 daily SMS text messages over 13 days. CONCLUSIONS: Across rural and urban contexts in South Africa, 2wT was noninferior to routine in-person visits for AE ascertainment, demonstrating 2wT safety. The 2wT approach also significantly reduced the follow-up visit workload, improving efficiency. These results strongly suggest that 2wT provides quality VMMC follow-up and should be adopted at scale. Adaptation of the 2wT telehealth approach to other acute follow-up care contexts could extend these gains beyond VMMC. TRIAL REGISTRATION: ClinicalTrials.gov NCT04327271; https://www.clinicaltrials.gov/ct2/show/NCT04327271.

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BACKGROUND: Voluntary medical male circumcision (VMMC) is a safe and effective HIV prevention strategy. However, adherence to recommended in-person, postoperative follow-up is inefficient for procedures with few adverse events. Two-way texting (2wT)-based follow-up appears to be a safe and an efficient alternative to scheduled clinic visits for low-risk patients who underwent VMMC. To ensure that 2wT responds to the needs of health care workers (HCWs) and patients, HCWs were closely involved in app design using a human-centered design (HCD) approach. OBJECTIVE: Embedded within an ongoing randomized controlled trial of 2wT in South Africa and complementary HCD processes of 2wT app optimization, this qualitative study aimed to use key informant interviews (KIIs) to explore the thoughts, suggestions, and opinions on and perceptions of 2wT's usability and acceptability among HCWs involved in 2wT implementation in both urban and rural South Africa. METHODS: A total of 7 HCWs using 2wT in Gauteng and the North West province participated in KIIs regarding the usability and acceptability of 2wT. HCWs were asked for their opinions on 2wT as a viable, useful, appropriate, and accessible method of postoperative VMMC care. They were also asked about 2wT-related working, exploring areas where 2wT could add to or reduce their daily tasks. The KII data were explored, coded, and analyzed by 3 qualitative researchers using thematic content analysis and the ATLAS.ti (ATLAS.ti Scientific Software Development GmbH) software. RESULTS: Most HCWs felt confident, comfortable, satisfied, and well supported using a 2wT-based follow-up as an alternative to in-person clinical reviews. They felt that 2wT was easy to use and required little technical support after initial mentoring on how to use the 2wT system. Few noted safety concerns, as men can receive clinical guidance, reassurance, and referral via 2wT. Although fewer in-person visits reduced the in-person review workload and eased clinical flow, HCWs noted the added burden of having to interact with clients via SMS text messages on evenings or weekends. HCWs reinforced the need for enhanced postoperative counseling to ensure that 2wT patients could recognize and understood how to respond to early signs of complications. HCWs suggested a rotation to spread the evening and weekend workload and ensure swift patient responses. CONCLUSIONS: In this formative qualitative study focused on HCWs, 2wT was a highly usable alternative to in-person postoperative reviews for patients who underwent VMMC in South Africa. The HCD processes likely improved the usability and acceptability of 2wT for HCWs. HCWs supported the scale-up of 2wT given the distance from the clinic to the men's homes and the potential for reducing workload. To ensure success, providers urged sensitizing patients to the fact that 2wT augments, but does not replace, the existing after-hours and emergency care services.

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Introduction: Voluntary medical male circumcision (VMMC) clients are required to attend multiple post-operative follow-up visits in South Africa. However, with demonstrated VMMC safety, stretched clinic staff in SA may conduct more than 400,000 unnecessary reviews for males without complications, annually. Embedded into a randomized controlled trial (RCT) to test safety of two-way, text-based (2wT) follow-up as compared to routine in-person visits among adult clients, the objective of this study was to compare 2wT and routine post-VMMC care costs in rural and urban South African settings. Methods: Activity-based costing (ABC) estimated the costs of post-VMMC care, including counselling, follow-ups, and tracing in $US dollars. Transportation for VMMC and follow-up was provided for rural clients in outreach settings but not for urban clients in static sites. Data were collected from National Department of Health VMMC forms, RCT databases, and time-and-motion surveys. Sensitivity analysis presents different follow-up scenarios. We hypothesized that 2wT would save per-client costs overall, with higher savings in rural settings. Results: VMMC program costs were estimated from 1,084 RCT clients: 537 in routine care and 547 in 2wT. On average, 2wT saved $3.56 per client as compared to routine care. By location, 2wT saved $7.73 per rural client and increased urban costs by $0.59 per client. 2wT would save $2.16 and $7.02 in follow-up program costs if men attended one or two post-VMMC visits, respectively. Conclusion: Quality 2wT follow-up care reduces overall post-VMMC care costs by supporting most men to heal at home while triaging clients with potential complications to timely, in-person care. 2wT saves more in rural areas where 2wT offsets transportation costs. Minimal additional 2wT costs in urban areas reflect high care quality and client engagement, a worthy investment for improved VMMC service delivery. 2wT scale-up in South Africa could significantly reduce overall VMMC costs while maintaining service quality.

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Compelling evidence from three randomised controlled trials, which showed that voluntary medical male circumcision (VMMC) reduces HIV acquisition from women to men by up to 60%, led to WHO recommending that VMMC be implemented in 14 priority countries. As one of the priority countries, Eswatini aimed to reach 80% VMMC coverage among boys and men aged 10-49 years since programme inception in 2009. By the end of 2019, however, the country had reached a modest 40%. VMMC is intrinsically tied to perceptions of masculinity and male gender identity. Comprehending the role of context-specific masculinity as it relates to VMMC may contribute to our understanding of community attitudes towards VMMC and men's decision-making. Drawing on focus group discussion data, this study aimed to explore the linkage between sexuality, masculinity and health interventions within Eswatini. Using critical discourse analysis, the study identified two discourses: sexuality, masculinity and circumcision, and income, masculinity, and circumcision. In the first discourse, participants constructed discursive linkages between circumcision as an adult and loss of penile sensitivity, decreased libido and sexual performance, and adverse events. The second discourse, income, masculinity, and circumcision located circumcision within the social and material realities faced by Swazi men, gender norms and provision within family structures.

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BACKGROUND: Mobile HIV testing approaches are a key to reaching the global targets of halting the HIV epidemic by 2030. Importantly, the number of clients reached through mobile HIV testing approaches, need to remain high to maintain the cost-effectiveness of these approaches. Advances in rapid in-vitro tests such as INSTI® HIV-1/HIV-2 (INSTI) which uses flow-through technologies, offer opportunities to reduce the HIV testing time to about one minute. Using data from a routine mobile HTS programme which piloted the use of the INSTI point-of-care (POC) test, we sought to estimate the effect of using a faster test on client testing volumes and the number of people identified to be living with HIV, in comparison with standard of care HIV rapid tests. METHODS: In November 2019, one out of four mobile HTS teams operating in Ekurhuleni District (South Africa) was randomly selected to pilot the field use of INSTI-POC test as an HIV screening test (i.e., the intervention team). We compared the median number of clients tested for HIV and the number of HIV-positive clients by the intervention team with another mobile HTS team (matched on performance and area of operation) which used the standard of care (SOC) HIV screening test (i.e., SOC team). RESULTS: From 19 to 20 December 2019, the intervention team tested 7,403 clients, and the SOC team tested 2,426 clients. The intervention team tested a median of 442 (IQR: 288-522) clients/day; SOC team tested a median of 97 (IQR: 40-187) clients/day (p<0.0001). The intervention team tested about 180 more males/day compared to the SOC team, and the median number of adolescents and young adults tested/day by the intervention team were almost four times the number tested by the SOC team. The intervention team identified a higher number of HIV-positive clients compared to the SOC team (142 vs. 88), although the proportion of HIV-positive clients was lower in the intervention team due to the higher number of clients tested. CONCLUSIONS: This pilot programme provides evidence of high performance and high reach, for men and young people through the use of faster HIV rapid tests, by trained lay counsellors in mobile HTS units.

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BACKGROUND: There is a need for information and healthcare support for the fertility desires and contraceptive needs of people living with HIV (PLHIV) in order to provide safer conception support for sero-discordant couples wanting to safely conceive. A model to integrate sexual and reproductive health and HIV services was developed and implemented in a district hospital and six clinics in the eThekwini District, South Africa. METHODS: To evaluate the model's success, a cross-sectional survey was conducted before and after implementation of the model. As part of this evaluation, fertility desires of PLHIV (both male and female), and providers' perspectives thereof were explored. Changes in desires and attitudes after integration of services were investigated. RESULTS: Forty-six healthcare providers and 269 clients (48 male, 221 female) were surveyed at baseline, and 44 providers and 300 clients (70 male, 230 female) at endline. Various factors including relationship status, parity and antiretroviral treatment (ART) access influenced PLHIVs' desires for children. Concerns for their own and their child's health negatively impacted on PLHIV's fertility desires. These concerns declined after integration of services. Similarly, providers' concerns about PLHIV having children decreased after the implementation of the model. CONCLUSIONS: Integrated services are important to facilitate provision of information on contraceptive options as well as safer conception information for PLHIV who want to have children.

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BACKGROUND: People living in rural areas have limited access to condoms owing to distance, cost and time involved in travelling to public health facilities, around which most condom distribution efforts are centralised. OBJECTIVE: In an effort to increase access to condoms in these areas, we explored the feasibility and efficacy of condom distribution by placing 'condocans' on trees along informal footpaths used by residents. METHODS: From October 2012, steel condocans, typically seen in clinic settings, were erected on trees along pathways in bushy areas with high levels of foot traffic at several rural locations in the Umgungundlovu district of KwaZulu-Natal Province, South Africa (SA). Because of their location, the condocans were referred to as 'bushcans'. Condom uptake was closely monitored, and the bushcans were restocked when necessary. RESULTS: Following the introduction of the bushcans, male condom distribution increased by 237% from October 2012 to December 2012. Condom distribution in these areas increased on average by 187% from October 2012 to October 2015, with more than 408 000 condoms distributed over the 3-year period using the bushcans alone. Discussions with residents revealed that they were pleased about the increased access to condoms via the bushcans, and they recommended other areas for potential implementation of this initiative. CONCLUSIONS: The bushcan initiative highlighted the fact that condoms are not as easily accessible to all South Africans as is often thought. By providing access to condoms in a discreet and convenient manner, the bushcans have the potential to increase access to condoms in other rural and periurban areas in SA where communities face similar barriers to access.

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BACKGROUND: New designs of female condom have been developed to reduce costs and improve acceptability. To secure regulatory approvals, clinical studies are needed to verify performance. We aimed to assess the functional performance and safety of three new condom types-the Woman's Condom, the VA worn-of-women (wow) Condom Feminine, and the Cupid female condom-against the existing second-generation female condom (FC2). METHODS: We did a randomised controlled, non-inferiority, four-period crossover trial at three sites in Shanghai, China, and one site in Durban, South Africa, between May 1, 2011, and Jan 31, 2012. Participants aged 18-45 years who were sexually active, monogamous, not pregnant, and not sex workers, were eligible for inclusion if they were literate, had no known allergies to the study products; used a reliable, non-barrier method of contraception, and had no visible or reported sexually transmitted infections. We used a computer-generated randomisation sequence with a Williams square design of size four to assign patients (1:1:1:1) to the FC2 control device, or the Woman's, VA wow, or Cupid condoms, with 12 potential allocations. Randomisation was stratified by site. Participants were not masked to condom type, but allocation was concealed from study investigators. The primary non-inferiority endpoints were total clinical failure and total female condom failure, with a non-inferiority margin of 3%. Women were asked to use five of each condom type and were interviewed after use of each type. We also assessed safety data for each type. We did both per-protocol and intention-to-treat analyses. We calculated frequencies and percentages for each failure event and estimated differences in performance with a generalised estimating equation model. This study is registered, number DOH-27-0113-4271. FINDINGS: 616 women were assessed for eligibility, of whom 600 were randomly assigned to condom-type order (30, 120, and 150 women in the three sites in China, and 300 women in the site in South Africa). 572 women completed follow-up, with at least one condom of each type. Total female condom failure was 3·43% for FC2, 3·85% for the Woman's Condom (difference 0·42%, 90% CI -1·42 to 2·26), 3·02% for VA wow (-0·42%, -1·86 to 1·32), and 4·52% for Cupid (1·09%, -0·60 to 2·78); total clinical failure was 2·88%, 3·05% (0·17%, -1·48 to 1·81), 2·49% (-0·25%, -1·75 to 1·26), and 3·87% (0·99%, -0·55 to 2·52), respectively. Only two (<1%) participants, in South Africa, reported serious adverse events, unrelated to use of the study products. INTERPRETATION: Non-inferiority was shown for all condom failure events for the three new devices versus the FC2, within the predefined margin. FUNDING: Universal Access to Female Condoms (UAFC).

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BACKGROUND: To avoid selection bias in clinical trials, random allocation concealment is crucial to ensure that participants and or researchers remain unaware of assignments. PURPOSE: We aimed to design an allocation concealment method that reduced the possibility of selection bias for a randomized, open-label, crossover trial to evaluate device function of four female condom (FC) types. METHODS: Using scratch card technology, we devised a simple method of concealment, whereby the treatment sequence was printed on a single card for each participant, and the codes for each treatment in the sequence were concealed beneath foil squares on a stiff A6-sized card. On the first and subsequent follow-up visits, the foil corresponding to that visit was scratched from the square to reveal the condom type allocation for the next condom-use period. Staff in the South African and Chinese trial sites were trained in use and care of the card, and on completion of the study completed a questionnaire on their experience of use. RESULTS: Research staff in both countries found the card easy to use and those who had previously used the sequentially numbered, opaque, sealed envelopes (SNOSE) system for random allocation reported the scratch card easier to use. Research staff most commonly used a coin to remove the foil square and some used their fingernails. In both South Africa and China, no errors in allocation sequence were found during study monitoring. LIMITATIONS: Scratch card system of allocation cannot be printed in-house. CONCLUSIONS: This novel, effective method of concealment for a crossover random allocation was well liked by study staff. The most important advantage of this method is the ability to conceal consecutive allocations of a crossover design using a single card, thus eliminating the need for multiple envelopes per participant. While we used this method in a clinical trial of FCs, it could be employed in a range of other clinical trials and other randomized studies.

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BACKGROUND: The rates of death are high among patients with coinfection with tuberculosis and the human immunodeficiency virus (HIV). The optimal timing for the initiation of antiretroviral therapy in relation to tuberculosis therapy remains controversial. METHODS: In an open-label, randomized, controlled trial in Durban, South Africa, we assigned 642 patients with both tuberculosis and HIV infection to start antiretroviral therapy either during tuberculosis therapy (in two integrated-therapy groups) or after the completion of such treatment (in one sequential-therapy group). The diagnosis of tuberculosis was based on a positive sputum smear for acid-fast bacilli. Only patients with HIV infection and a CD4+ cell count of less than 500 per cubic millimeter were included. All patients received standard tuberculosis therapy, prophylaxis with trimethoprim-sulfamethoxazole, and a once-daily antiretroviral regimen of didanosine, lamivudine, and efavirenz. The primary end point was death from any cause. RESULTS: This analysis compares data from the sequential-therapy group and the combined integrated-therapy groups up to September 1, 2008, when the data and safety monitoring committee recommended that all patients receive integrated antiretroviral therapy. There was a reduction in the rate of death among the 429 patients in the combined integrated-therapy groups (5.4 deaths per 100 person-years, or 25 deaths), as compared with the 213 patients in the sequential-therapy group (12.1 per 100 person-years, or 27 deaths); a relative reduction of 56% (hazard ratio in the combined integrated-therapy groups, 0.44; 95% confidence interval, 0.25 to 0.79; P=0.003). Mortality was lower in the combined integrated-therapy groups in all CD4+ count strata. Rates of adverse events during follow-up were similar in the two study groups. CONCLUSIONS: The initiation of antiretroviral therapy during tuberculosis therapy significantly improved survival and provides further impetus for the integration of tuberculosis and HIV services. (ClinicalTrials.gov number, NCT00398996.)

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