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Noah Kiwanuka

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Profile EDCTP Fellowship 1

Project Title

A randomised trial to assess retention rates using mobile phones versus contact tracing, andto characterize trends in HIV-1 prevalence and incidence in a potential HIV vaccine efficacy population of fishing communities around Lake Victoria, Uganda

EDCTP Project

TA.2011.40200.035

EDCTP Program

EDCTP1

EDCTP Project Call

Senior Fellowship (SF)

Project Objectives

Primary Objective: 1. To determine whether retention in the study will be significantly different among persons followed up using mobile telephones (calls and text messages) compared to physical contact tracing. Secondary Objectives: 1. To characterize trends in HIV-1 incidence and prevalence among HIV risk individuals in fishing communities around Lake Victoria 2. To determine the level and determinants of willingness to participate in HIV vaccine efficacy studies among HIV-1 risk individuals in fishing communities around Lake Victoria 3. To build clinical trials-specific statistical and data management capacity to provide support and skills to clinical trial investigators, faculty and students.

Study Design

Randomised Controlled Trial

Project Summary

The aim of the project is to perform an assessment of the suitability of HIV risk individuals in fishing communities around Lake Victoria for HIV vaccine efficacy trials through characterization of recruitment, retention, willingness to participate (WTP), and trends in HIV prevalence and incidence, and to build statistical and data management capacity for clinical trials research. The research questions are: (1) does mobile phone reminder yield significantly higher retention rate than physical contact tracing among HIV high risk persons in fishing communities in Uganda?; (2) what are the trends in HIV-1 incidence and prevalence among HIV risk individuals in fishing communities around Lake Victoria?; (3) what is the level of determinants of willingness to participate in HIV vaccine efficacy studies among HIV-1 risk individuals in fishing communities around Lake Victoria

Host Organisation

Department Institution Country
Medical Research Council Programme on AIDS - Uganda Virus Research Institute (MRC/UVRI) Uganda

Sites

Results & Outcomes

Summary of Activities and Findings A total of 662 participants aged 13 -49 years from four fishing communities, screened for high risk behaviours were enrolled and randomized 1:1 to mobile phone arm where they were reminded by a phone call (331) or physical tracing arm (331). Participants were followed up mimicking a vaccine efficacy schedule at 0, 1, 2, 3,6,12 and 18 months. At each visit a semi-structured questionnaire was administered on socio demographics, risk behaviors for HIV and STIs, and treatment seeking behavior. Participants were reminded about an upcoming visit by a phone call or physical contact tracing, 7 days before and 3 days past the scheduled visit if by that time they had not turned up. Each visit had a window of +/- 1 week. Retention was determined and compared across study arms. Findings: Analysis is complete for data up to month 12. By 12 months follow up visits, overall the physical tracing arm had better retention rates compared to the phone but significant differences were only observed at month 12. Month 1, (79.5% vs 78.3%, respectively) month 2, (87.6% vs 87.3%), month 3, (86.7% vs 83.4%), month 6, (87.4 vs 85.5%) with the highest rate at month 12, (91.5% vs 82.5%; p- value = 0.001). Total compliance at all visits by month 12 was 59.4% overall and there was no significant difference between arms (57.7% vs 61.0%). Factors significantly associated with retention were resident on island (54.8% vs 64.6%) p value 0.01, tribe and attainment of secondary education.