Novel community health worker strategy for HIV service engagement in a hyperendemic community in Rakai, Uganda: A pragmatic, cluster-randomized trial

Abstract

Background: Effective implementation strategies are needed to increase engagement in HIV services in hyperendemic settings. We conducted a pragmatic cluster-randomized trial in a high-risk, highly mobile fishing community (HIV prevalence: approximately 38%) in Rakai, Uganda, to assess the impact of a community health worker-delivered, theory-based (situated Information, Motivation, and Behavior Skills), motivational interviewing-informed, and mobile phone application-supported counseling strategy called "Health Scouts" to promote engagement in HIV treatment and prevention services.

Methods and findings: The study community was divided into 40 contiguous, randomly allocated clusters (20 intervention clusters, n = 1,054 participants at baseline; 20 control clusters, n = 1,094 participants at baseline). From September 2015 to December 2018, the Health Scouts were deployed in intervention clusters. Community-wide, cross-sectional surveys of consenting 15 to 49-year-old residents were conducted at approximately 15 months (mid-study) and at approximately 39 months (end-study) assessing the primary programmatic outcomes of self-reported linkage to HIV care, antiretroviral therapy (ART) use, and male circumcision, and the primary biologic outcome of HIV viral suppression (<400 copies/mL). Secondary outcomes included HIV testing coverage, HIV incidence, and consistent condom use. The primary intent-to-treat analysis used log-linear binomial regression with generalized estimating equation to estimate prevalence risk ratios (PRR) in the intervention versus control arm. A total of 2,533 (45% female, mean age: 31 years) and 1,903 (46% female; mean age 32 years) residents completed the mid-study and end-study surveys, respectively. At mid-study, there were no differences in outcomes between arms. At end-study, self-reported receipt of the Health Scouts intervention was 38% in the intervention arm and 23% in the control arm, suggesting moderate intervention uptake in the intervention arm and substantial contamination in the control arm. At end-study, intention-to-treat analysis found higher HIV care coverage (PRR: 1.06, 95% CI: 1.01 to 1.10, p = 0.011) and ART coverage (PRR: 1.05, 95% CI: 1.01 to 1.10, p = 0.028) among HIV-positive participants in the intervention compared with the control arm. Male circumcision coverage among all men (PRR: 1.05, 95% CI: 0.96 to 1.14, p = 0.31) and HIV viral suppression among HIV-positive participants (PRR: 1.04, 95% CI: 0.98 to 1.12, p = 0.20) were higher in the intervention arm, but differences were not statistically significant. No differences were seen in secondary outcomes. Study limitations include reliance on self-report for programmatic outcomes and substantial contamination which may have diluted estimates of effect.

Conclusions: A novel community health worker intervention improved HIV care and ART coverage in an HIV hyperendemic setting but did not clearly improve male circumcision coverage or HIV viral suppression. This community-based, implementation strategy may be a useful component in some settings for HIV epidemic control.

Trial registration: ClinicalTrials.gov NCT02556957.

Conflict of interest statement

I have read the journal's policy and the authors of this manuscript have the following competing interests: emocha Mobile Health Inc. developed and supported the smartphone application used in this study. LC and RB are entitled to royalties on certain non-research revenue generated by this company and own company equity. Specific to this study, LC and RB have and will receive no royalties or compensation from emocha Mobile Health Inc.. This arrangement has been reviewed and approved by the Johns Hopkins University in accordance with its conflict of interest policies. MW receive a consulting fee from the Rakai Health Sciences Program, which has been reported to the Johns Hopkins Conflict of Interest office. This consultancy did not influence the manuscript under review. RG reports personal fees from Rakai Health Sciences Program, outside the submitted work; and RG's contribution to this publication/presentation was as a member of the Board of Directors of the Rakai Health Sciences Program. This arrangement has been reviewed and approved by the Johns Hopkins University in accordance with its conflict of interest policies. All other study team members have declared that no competing interests exist.

Figures

Fig 1. Study flow diagram.

Three surveys were conducted (baseline, mid-study, and end-study). Participants could be LTFU from 1 survey to the next, RTFU from the baseline to end-study survey, be new to a survey, or move between I and C clusters between surveys. C, control; I, intervention; LTFU, lost-to-follow-up; RTFU, return-to-follow-up.