Short-term effectiveness of a community health worker intervention for HIV-infected pregnant women in Tanzania to improve treatment adherence and retention in care: A cluster-randomized trial.

INTRODUCTION: Community health workers (CHWs) are lay workers who have the potential to enhance services to prevent mother-to-child HIV transmission (PMTCT) and improve the health of women living with HIV infection. We conducted a cluster-randomized trial of an intervention to integrate CHWs with 'Option B+' PMTCT services in Shinyanga Region, Tanzania. METHODS: The intervention was implemented for 11 months and included four integrated components: 1) formal linkage of CHWs to health facilities; 2) CHW-led antiretroviral therapy (ART) adherence counseling; 3) loss to follow-up tracing by CHWs; and 4) distribution of Action Birth Cards (ABCs), a birth planning tool. We cluster-randomized 32 facilities offering PMTCT services, within strata of size, to the intervention (n = 15) or comparison (standard of care, n = 17) groups. Intervention effectiveness was determined with a difference-in-differences strategy based on clinical and pharmacy data from HIV-infected postpartum women at baseline (births in 2014) and endline (births April-Oct 2015). The primary outcome was retention in care between 60 and 120 days postpartum. Secondary outcomes included ART initiation, timing of ART initiation (as measured by week of gestation), and ART adherence 90 days postpartum, measured using the medication possession ratio (MPR≥95%). RESULTS: Intervention and comparison facilities were similar at baseline. Data were collected from 1,152 and 678 mother-infant pairs at baseline and endline, respectively. There were no significant differences in retention in care, ART initiation, or timing of ART initiation between the intervention and control groups. Adherence (MPR≥95%) at 90 days postpartum was 11.3 percentage points higher in the intervention group in ITT analyses (95% CI: -0.7, 23.3, p = 0.06), though this effect was attenuated after adjusting for baseline imbalance (9.5 percentage points, 95% CI: -2.9, 22.0, p = 0.13). Among only sites that had the greatest fidelity to the intervention, however, we found a stronger effect on adherence (13.6 percentage points, 95% CI: 2.5, 24.6). CONCLUSIONS: Despite being feasible and acceptable, the CHW-based intervention did not have strong effects on most PMTCT indicators. CHW involvement in PMTCT programs may improve ART adherence among HIV-infected postpartum women, however, and success appears heavily dependent on program implementation. TRIAL REGISTRATION: Registry for International Development Impact Evaluations (RIDIE, ID 552553838b402) and ClinicalTrials.gov (NCT03058484).

Microbicides development programme: engaging the community in the standard of care debate in a vaginal microbicide trial in Mwanza, Tanzania.

BACKGROUND: HIV prevention research in resource-limited countries is associated with a variety of ethical dilemmas. Key amongst these is the question of what constitutes an appropriate standard of health care (SoC) for participants in HIV prevention trials. This paper describes a community-focused approach to develop a locally-appropriate SoC in the context of a phase III vaginal microbicide trial in Mwanza City, northwest Tanzania. METHODS: A mobile community-based sexual and reproductive health service for women working as informal food vendors or in traditional and modern bars, restaurants, hotels and guesthouses has been established in 10 city wards. Wards were divided into geographical clusters and community representatives elected at cluster and ward level. A city-level Community Advisory Committee (CAC) with representatives from each ward has been established. Workshops and community meetings at ward and city-level have explored project-related concerns using tools adapted from participatory learning and action techniques e.g. chapati diagrams, pair-wise ranking. Secondary stakeholders representing local public-sector and non-governmental health and social care providers have formed a trial Stakeholders' Advisory Group (SAG), which includes two CAC representatives. RESULTS: Key recommendations from participatory community workshops, CAC and SAG meetings conducted in the first year of the trial relate to the quality and range of clinic services provided at study clinics as well as broader standard of care issues. Recommendations have included streamlining clinic services to reduce waiting times, expanding services to include the children and spouses of participants and providing care for common local conditions such as malaria. Participants, community representatives and stakeholders felt there was an ethical obligation to ensure effective access to antiretroviral drugs and to provide supportive community-based care for women identified as HIV positive during the trial. This obligation includes ensuring sustainable, post-trial access to these services. Post-trial access to an effective vaginal microbicide was also felt to be a moral imperative. CONCLUSION: Participatory methodologies enabled effective partnerships between researchers, participant representatives and community stakeholders to be developed and facilitated local dialogue and consensus on what constitutes a locally-appropriate standard of care in the context of a vaginal microbicide trial in this setting. TRIAL REGISTRATION: Current Controlled Trials ISRCTN64716212.