Applying behavioural economics principles to increase demand for free HIV testing services at private doctor-led clinics in Johannesburg, South Africa: A randomised controlled trial.

Background: Expanding free HIV testing service (HTS) access to include private clinics could increase testing rates. A donor funded programme, GP Care Cell, offered free HIV testing at selected private doctor-led clinics but uptake was low. We investigated whether HTS demand creation materials that used behavioural economics principles could increase demand for HIV testing at these clinics. Methods: We conducted a randomised controlled trial in Johannesburg, South Africa (January-April 2022) distributing brochures promoting HTS to adults in five private doctor-led clinic catchment areas. Individuals were randomised to receive three brochure types: (1) "Standard of care" (SOC) advertising a free HIV test and ART; (2) "Healthy lifestyle screening" promoted free low-cost health screenings in addition to HTS; and (3) "Recipient of care voucher" leveraged loss aversion and the endowment effect by highlighting the monetary value of free HTS. The primary outcome was presenting at the clinic following exposure to the brochures. Logistic regression compared outcomes between arms. Results: Of the 12,129 brochures distributed, 658 were excluded because of errors or duplicates and 11,471 were analysed. About 59% of brochure recipients were male and 50,3% were aged 25-34 years. In total, 448 (3.9%) brochure recipients presented at the private doctor-led clinics of which 50.7% were males. There were no significant differences in clinic presentation between the healthy lifestyle screening and SOC arm (Adjusted Odds Ratio [AOR] 1.02; 95% CI 0.79-1.32), and similarly between the recipient of care voucher and SOC arm (AOR 1.08; 95% CI 0.84-1.39). Individuals were more likely to attend clinics that were centrally located with visible branding for HTS (AOR=5.30; 95% CI: 4.14-6.79). Conclusion: Brochures that used behavioural insights did not increase demand for HTS at private doctor-led clinics. However, consistent distribution of the brochures may have potential to increase HIV testing uptake at highly visible private doctor-led clinics.

Quasi-experimental evaluation of a financial incentive for first-dose COVID-19 vaccination among adults aged ≥60 years in South Africa.

INTRODUCTION: COVID-19 vaccination coverage in South Africa (RSA) remains low despite increased access to vaccines. On 1 November 2021, RSA introduced the Vooma Voucher programme which provided a small guaranteed financial incentive, a Vooma Voucher redeemable at grocery stores, for COVID-19 vaccination among older adults, a population most vulnerable to serious illness, hospitalisation and death. However, the association of financial incentives with vaccination coverage remains unclear. METHODS: We evaluated the association of the conditional economic incentive programme with first-dose vaccination rates among adults (aged ≥60 years) through a quasi-experimental cohort study. The Vooma Voucher programme was a nationwide vaccination incentive programme implemented for adults aged ≥60 years from 1 November 2021 to 28 February 2022. We ran ITS models to evaluate the Vooma Voucher programme at national and provincial levels. We used data between 1 October 2021 and 27 November 2021 in models estimated at the daily level. Individuals who received their first vaccine dose received a text message to access a ZAR100 ($~7) voucher that was redeemable at grocery stores. RESULTS: The Vooma Voucher programme was associated with a 7.15%-12.01% increase in daily first-dose vaccinations in November 2021 compared with late October 2021. Overall, the incentive accounted for 6476-10 874 additional first vaccine doses from 1 November to 27 November 2021, or 8.31%-13.95% of all doses administered to those aged ≥60 years during that period. This result is robust to the inclusion of controls for the number of active vaccine delivery sites and for the nationwide Vooma vaccination weekend initiative (12 November to 14 November), both of which also increased vaccinations through expanded access to vaccines and demand creation activities. CONCLUSIONS: Financial incentives for COVID-19 vaccination led to a modest increase in first-dose vaccinations among older adults in RSA. Financial incentives and expanded access to vaccines may result in higher vaccination coverage. TRIAL REGISTRATION NUMBER SANCTR: DOH-27-012022-9116.

Fast-track treatment initiation counselling in South Africa: A cost-outcomes analysis.

INTRODUCTION: In 2016, under its new National Adherence Guidelines (AGL), South Africa formalized an existing model of fast-track HIV treatment initiation counselling (FTIC). Rollout of the AGL included an evaluation study at 24 clinics, with staggered AGL implementation. Using routinely collected data extracted as part of the evaluation study, we estimated and compared the costs of HIV care and treatment from the provider's perspective at the 12 clinics implementing the new, formalized model (AGL-FTIC) to costs at the 12 clinics continuing to implement some earlier, less formalized, model that likely varied across clinics (denoted here as early-FTIC). METHODS: This was a cost-outcome analysis using standard methods and a composite outcome defined as initiated antiretroviral therapy (ART) within 30 days of treatment eligibility and retained in care at 9 months. Using patient-level, bottom-up resource-utilization data and local unit costs, we estimated patient-level costs of care and treatment in 2017 U.S. dollars over the 9-month evaluation follow-up period for the two models of care. Resource use and costs, disaggregated by antiretroviral medications, laboratory tests, and clinic visits, are reported by model of care and stratified by the composite outcome. RESULTS: A total of 350/343 patients in the early-FTIC/AGL-FTIC models of care are included in this analysis. Mean/median costs were similar for both models of care ($135/$153 for early-FTIC, $130/$151 for AGL-FTIC). For the subset achieving the composite outcome, resource use and therefore mean/median costs were similar but slightly higher, reflecting care consistent with treatment guidelines ($163/$166 for early-FTIC, $168/$170 for AGL-FTIC). Not surprisingly, costs for patients not achieving the composite outcome were substantially less, mainly because they only had two or fewer follow-up visits and, therefore, received substantially less ART than patients who achieved the composite outcome. CONCLUSION: The 2016 adherence guidelines clarified expectations for the content and timing of adherence counseling sessions in relation to ART initiation. Because clinics were already initiating patients on ART quickly by 2016, little room existed for the new model of fast-track initiation counseling to reduce the number of pre-ART clinic visits at the study sites and therefore to reduce costs of care and treatment. TRIAL REGISTRATION: Clinical Trial Number: NCT02536768.

"Patients are not the same, so we cannot treat them the same" - A qualitative content analysis of provider, patient and implementer perspectives on differentiated service delivery models for HIV treatment in South Africa.

INTRODUCTION: In 2014, the South African government adopted a differentiated service delivery (DSD) model in its "National Adherence Guidelines for Chronic Diseases (HIV, TB and NCDs)" (AGL) to strengthen the HIV care cascade. We describe the barriers and facilitators of the AGL implementation as experienced by various stakeholders in eight intervention and control sites across four districts. METHODS: Embedded within a cluster-randomized evaluation of the AGL, we conducted 48 in-depth interviews (IDIs) with healthcare providers, 16 IDIs with Department of Health and implementing partners and 24 focus group discussions (FGDs) with three HIV patient groups: new, stable and those not stable on treatment or not adhering to care. IDIs were conducted from August 2016 to August 2017; FGDs were conducted in January to February 2017. Content analysis was guided by the Consolidated Framework for Implementation Research. Findings were triangulated among respondent types to elicit barriers and facilitators to implementation. RESULTS: New HIV patients found counselling helpful but intervention respondents reported sub-optimal counselling and privacy concerns as barriers to initiation. Providers felt insufficiently trained for this intervention and were confused by the simultaneous rollout of the Universal Test and Treat strategy. For stable patients, repeat prescription collection strategies (RPCS) were generally well received. Patients and providers concurred that RPCS reduced congestion and waiting times at clinics. There was confusion though, among providers and implementers, around implementation of RPCS interventions. For patients not stable on treatment, enhanced counselling and tracing patients lost-to-follow-up were perceived as beneficial to adherence behaviours but faced logistical challenges. All providers faced difficulties accessing data and identifying patients in need of tracing. Congestion at clinics and staff attitude were perceived as barriers preventing patients returning to care. CONCLUSIONS: Implementation of DSD models at scale is complex but this evaluation identified several positive aspects of AGL implementation. The positive perception of RPCS interventions and challenges managing patients not stable on treatment aligned with results from the larger evaluation. While some implementation challenges may resolve with experience, ensuring providers and implementers have the necessary training, tools and resources to operationalize AGL effectively is critical to the overall success of South Africa's HIV control strategy.

Effectiveness of interventions for unstable patients on antiretroviral therapy in South Africa: results of a cluster-randomised evaluation.

BACKGROUND: As loss from HIV care is an ongoing challenge globally, interventions are needed for patients who don't achieve or maintain ART stability. The 2015 South African National Adherence Guidelines (AGL) for Chronic Diseases include two interventions targeted at unstable patients: early tracing of patients who miss visits (TRIC) and enhanced adherence counselling (EAC). METHODS: As part of a cluster-randomised evaluation at 12 intervention and 12 control clinics in four provinces, intervention sites implemented the AGL interventions, while control sites retained standard care. We report on outcomes of EAC for patients with an elevated viral load (>400 copies/ml) and for TRIC patients who missed a visit by >5 days. We estimated risk differences (RD) of 3 and 12-month viral resuppression (<400 copies/ml) and 12-month retention with cluster adjustment using generalised estimating equations and controlled for imbalances using difference-in-differences compared to all eligible in 2015, prior to intervention roll-out. RESULTS: For EAC, we had 358 intervention and 505 control site patients (61% female, median ART initiation CD4 count 154 cells/µl). We found no difference between arms in 3-month resuppression (RD: -1.7%; 95%CI: -4.3% to 0.9%), but <20% of patients had a repeat viral load within 3 months (19.8% intervention, 13.5% control). Including the entire clinic population eligible for EAC with a repeat viral load at all evaluation sites (n = 934), intervention sites showed a small increase in 3-month resuppression (28% vs. 25%, RD 3.0%; 95%CI: -2.7% to 8.8%). Adjusting for baseline differences increased the RD to 8.1% (95% CI: -0.1% to 17.2%). However, we found no differences in 12-month suppression (RD: 1.5%; 95% CI: -14.1% to 17.1% but suppression was low overall at 40%) or retention (RD: 2.8%; 95% CI: -7.5% to 13.2%). For TRIC, we enrolled 155 at intervention sites and 248 at control sites (44% >40 years, 67% female, median CD4 count 212 cells/µl). We found no difference between groups in return to care by 12 months (RD: -6.8%; 95% CI: -17.7% to 4.8%). During the study period, control sites continued to use tracing within standard care, however, potentially masking intervention effects. CONCLUSIONS: Enhanced adherence counselling showed no benefit over 12 months. Implementation of the tracing intervention under the new guidelines was similar to the standard of care. Interventions that aim to return unstable patients to care should incorporate active monitoring to determine if the interventions are effective.

"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.

Poverty, food insufficiency and HIV infection and sexual behaviour among young rural Zimbabwean women.

BACKGROUND: Despite a recent decline, Zimbabwe still has the fifth highest adult HIV prevalence in the world at 14.7%; 56% of the population are currently living in extreme poverty. DESIGN: Cross-sectional population-based survey of 18-22 year olds, conducted in 30 communities in south-eastern Zimbabwe in 2007. OBJECTIVE: To examine whether the risk of HIV infection among young rural Zimbabwean women is associated with socio-economic position and whether different socio-economic domains, including food sufficiency, might be associated with HIV risk in different ways. METHODS: Eligible participants completed a structured questionnaire and provided a finger-prick blood sample tested for antibodies to HIV and HSV-2. The relationship between poverty and HIV was explored for three socio-economic domains: ability to afford essential items; asset wealth; food sufficiency. Analyses were performed to examine whether these domains were associated with HIV infection or risk factors for infection among young women, and to explore which factors might mediate the relationship between poverty and HIV. RESULTS: 2593 eligible females participated in the survey and were included in the analyses. Overall HIV prevalence among these young females was 7.7% (95% CI: 6.7-8.7); HSV-2 prevalence was 11.2% (95% CI: 9.9-12.4). Lower socio-economic position was associated with lower educational attainment, earlier marriage, increased risk of depression and anxiety disorders and increased reporting of higher risk sexual behaviours such as earlier sexual debut, more and older sexual partners and transactional sex. Young women reporting insufficient food were at increased risk of HIV infection and HSV-2. CONCLUSIONS: This study provides evidence from Zimbabwe that among young poor women, economic need and food insufficiency are associated with the adoption of unsafe behaviours. Targeted structural interventions that aim to tackle social and economic constraints including insufficient food should be developed and evaluated alongside behaviour and biomedical interventions, as a component of HIV prevention programming and policy.

'How poor are you?' -- a comparison of four questionnaire delivery modes for assessing socio-economic position in rural zimbabwe.

BACKGROUND: Assessing socio-economic position can be difficult, particularly in developing countries. Collection of socio-economic data usually relies on interviewer-administered questionnaires, but there is little research exploring how questionnaire delivery mode (QDM) influences reporting of these indicators. This paper reports on results of a trial of four QDMs, and the effect of mode on poverty reporting. METHODS: This trial was nested within a community-randomised trial of an adolescent reproductive health intervention conducted in rural Zimbabwe. Participants were randomly allocated to one of four QDMs (three different self-administered modes and one interviewer-administered mode); a subset was randomly selected to complete the questionnaire twice. Questions covered three socio-economic domains: i) ownership of sellable and fixed assets; ii) ability to afford essential items; and iii) food sufficiency. Statistical analyses assessed the association between QDM and reporting of poverty, and compared the extent of response agreement between questionnaire rounds. RESULTS: 96% (n = 1483) of those eligible took part; 395 completed the questionnaire twice. Reported levels of poverty were high. Respondents using self-administered modes were more likely to report being unable to afford essential items and having insufficient food. Among those completing the questionnaire twice using different modes, higher levels of poverty and food insufficiency were reported when they completed the questionnaire using a self-administered mode. CONCLUSION: These data suggest that QDM plays a significant role in how different socio-economic indicators are reported, and reminds us to consider the mode of collection when identifying indicators to determine socio-economic position.

How you ask really matters: randomised comparison of four sexual behaviour questionnaire delivery modes in Zimbabwean youth.

OBJECTIVE: A sexual health survey among rural Zimbabwean youth was used to compare the validity and reliability of sexual behaviour measures between four questionnaire delivery modes. METHODS: Using a random permuted block design, 1495 youth were randomised to one of four questionnaire delivery modes: self-administered questionnaire (SAQ=373); SAQ accompanied by an audio soundtrack (Audio-SAQ=376); face-to-face interview with sensitive questions placed in a confidential voting box (Informal confidential voting interview; ICVI=365); and audio computer-assisted survey instrument (ACASI=381). Key questions were selected a priori to compare item non-response and rates of reporting of sensitive behaviours between questionnaire delivery modes. Qualitative data were collected on perceived method acceptability (n=115). RESULTS: Item non-response was significantly higher with SAQ and Audio-SAQ than with ICVI and ACASI (p<0.001). After adjusting for covariates, the odds of reporting sexual activity among Audio-SAQ and ACASI users were twice as high as the odds for SAQ users (Audio-SAQ AOR=2.05 (95% CI 1.2 to 3.4); ACASI AOR=2.0 (95% CI 1.2 to 3.2)), with no evidence of reporting difference between ICVI and SAQ users (ICVI AOR=1.0 (95% CI 0.6 to 1.8)). ACASI users reported a lower age at first intercourse and were more likely to report a greater number of partners (mean difference=1.06; 95% CI 0.33 to 1.78; p=0.004). They reported an increased ability to answer questions honestly (p=0.004) and believed their answers would be kept secret. Participants claimed increased comprehension when hearing questions while reading them. ICVI users expressed difficulty answering sensitive questions, despite understanding that their answers were unknown to the interviewer. CONCLUSION: ACASI appears to reduce bias significantly, and is feasible and acceptable in resource-poor settings with low computer literacy. Its increased use would likely improve the quality of questionnaire data in general and sexual behaviour data specifically.

The Regai Dzive Shiri project: results of a randomized trial of an HIV prevention intervention for youth.

BACKGROUND: HIV prevention among young people in southern Africa is a public health priority. There is little rigorous evidence of the effectiveness of different intervention approaches. We describe findings of a cluster randomized trial of a community-based, multicomponent HIV, and reproductive health intervention aimed at changing social norms for adolescents in rural Zimbabwe. METHODS: Thirty rural communities were randomized to early or deferred implementation of the intervention in 2003. Impact was assessed in a representative survey of 18-22-year-olds after 4 years. Participants self-completed a questionnaire and gave a dried blood spot sample for HIV and herpes simplex virus-2 (HSV-2) antibody testing. Young women had a urinary pregnancy test. Analyses were by intention-to-treat and were adjusted for clustering. FINDINGS: Four thousand six hundred and eighty-four, 18-22-year-olds participated in the survey (97.1% of eligible candidates, 55.5% women). Just over 40% had been exposed to at least 10 intervention sessions. There were modest improvements in knowledge and attitudes among young men and women in intervention communities, but no impact on self-reported sexual behavior. There was no impact of the intervention on prevalence of HIV or HSV-2 or current pregnancy. Women in intervention communities were less likely to report ever having been pregnant. INTERPRETATION: Despite an impact on knowledge, some attitudes, and reported pregnancy, there was no impact of this intervention on HIV or HSV-2 prevalence, further evidence that behavioral interventions alone are unlikely to be sufficient to reverse the HIV epidemic. The challenge remains to find effective HIV prevention approaches for young people in the face of continued and unacceptably high HIV incidence, particularly among young women.

Field evaluation of diagnostic accuracy of an oral fluid rapid test for HIV, tested at point-of-service sites in rural Zimbabwe.

The objective of this study was to validate the use of OraQuick ADVANCE Rapid HIV-1/2 Antibody test (OraSure Technologies Inc., Bethlehem, PA) on oral fluid for a population-based HIV prevalence survey of rural youth in southeast Zimbabwe. The evaluation was conducted in patients presenting for voluntary counseling and testing at rural clinics. Each participant provided an oral fluid sample tested using OraQuick ADVANCE. In addition, dried blood specimens were collected and tested blind at the National Microbiology Reference Laboratory in Harare using two enzyme-linked immunosorbent assays (ELISA; Vironostika, Biomérieux BV, Boxtel, The Netherlands and Ani Labsystems, Ltd., Vantaa, Finland) with confirmatory Western blot (MP Diagnostics [formerly Genelabs Diagnostics], Medical Technology Promedt Consulting GMBH, St. Ingbert, Germany) for samples with discrepant results. Diagnostic accuracy of the oral fluid assay was determined against the ELISA/Western blot algorithm as gold standard. Five hundred and ninety-one participants took part in the study between February and July 2006. Sensitivity of the test on oral fluid was 100% (95% confidence interval [CI]: 97.9-100), and specificity was 100% (95% CI: 99.1-100). HIV prevalence based on the reference standard was 29.8% (95% CI: 26.1-33.5). This is one of the first validations of this rapid assay on oral fluid conducted in a general population to be reported in Africa. While there are some limitations with the assay (e.g., unlikely to detect those in early stages of HIV infection or with reduced viral load; altered accuracy in pregnancy) these limitations also apply to other rapid assays. The results showed the assay to be 100% accurate in determining HIV status, performed well in field settings, and can be considered suitable for use in epidemiologic surveys aiming to estimate HIV prevalence in general populations.

The Regai Dzive Shiri Project: a cluster randomised controlled trial to determine the effectiveness of a multi-component community-based HIV prevention intervention for rural youth in Zimbabwe--study design and baseline results.

OBJECTIVE: To assess the effectiveness of a community-based HIV prevention intervention for adolescents in terms of its impact on (1) HIV and Herpes simplex virus type 2 (HSV-2) incidence and on rates of unintended pregnancy and (2) reported sexual behaviour, knowledge and attitudes. METHODS: Cluster randomised trial of a multi-component HIV prevention intervention for adolescents based in rural Zimbabwe. Thirty communities were selected and randomised in 2003 to early or deferred intervention implementation. A baseline bio-behavioural survey was conducted among 6791 secondary school pupils (86% of eligibles) prior to intervention implementation. RESULTS: Baseline prevalences were 0.8% (95% CI: 0.6-1.0) for HIV and 0.2% (95% CI: 0.1-0.3%) for HSV-2. Four girls (0.12%) were pregnant. There was excellent balance between study arms. Orphans who made up 35% of the cohort were at increased risk of HIV [age-sex adjusted odds ratio 3.4 (95% CI: 1.7-6.5)]. 11.9% of young men and 2.9% of young women reported that they were sexually active (P < 0.001); however, there were inconsistencies in the sexual behaviour data. Girls were less likely to know about reproductive health issues than boys (P < 0.001) and were less likely to have used and to be able to access condoms (P < 0.001). CONCLUSION: This is one of the first rigorous evaluations of a community-based HIV prevention intervention for young people in southern Africa. The low rates of HIV suggest that the intervention was started before this population became sexually active. Inconsistency and under-reporting of sexual behaviour re-emphasise the importance of using externally validated measures of sexual risk reduction in behavioural intervention studies.

Association of genital shedding of herpes simplex virus type 2 and HIV-1 among sex workers in rural Zimbabwe.

INTRODUCTION: Herpes simplex virus type 2 (HSV-2) facilitates sexual acquisition of HIV-1 but data on transmission are less clear. In this study the interaction between genital shedding of HIV-1 and HSV-2 was explored among Zimbabwean sex workers. METHODS: Women (n = 214) were interviewed about genital symptoms. Blood samples were analysed for HIV-1 and HSV-2 antibodies, HIV-1 plasma viral load (PVL) and CD4 lymphocyte count and genital swabs for detection of HIV-1 and HSV-2 genital shedding, Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis, and a cervico-vaginal lavage (CVL) for quantitative measurement of HIV-1 shedding. Shedding analyses were undertaken on women co-infected with HSV-2 and HIV-1. RESULTS: A total of 124 women were co-infected with HIV-1 and HSV-2; 58 were infected with HSV-2 alone. Most HIV-1-infected women were co-infected with HSV-2 (95.4%). Genital HIV-1 shedding was detected in 84.3% of co-infected women and was associated with low CD4 cell count and high PVL but not with reported symptoms of genital herpes or genital shedding of HSV-2. There was no difference in HIV-1 shedding among women shedding HSV-2 (79.3%) and women not shedding HSV-2 (83.2%) (P = 0.64). The adjusted odds ratio for HIV-1 shedding between HSV-2 shedders and non-shedders was 0.8 [95% confidence interval (CI), 0.2-3.3]. HIV-1 PVL(log10) and CVL viral load(log10) were correlated (r = 0.38; 95%CI, 0.2-0.5). After adjusting for PVL, genital symptoms and age, HSV-2 shedding had no effect on CVL viral load (P = 0.13). CONCLUSION: Rate and quantity of HIV-1 genital shedding do not appear to be altered by presence of HSV-2 genital shedding.