Transport Study

Introduction

Incomplete adherence to HIV antiretroviral (ARV) therapy is the strongest predictor of viral load (VL), drug resistance and mortality [6-8]. While early reports find exceptional ARV adherence in resource limited countries (RLC)[9], structural barriers are an important cause of missed doses[2, 10, 11]. Our data suggest that treatment interruptions account for 90% of missed doses, that these increase with distance to clinic, and are a major cause of ARV resistance[3]. Nevirapine fixed-dose combination (FDC) therapy is particularly vulnerable to treatment interruptions due to differing half-lives and the subsequent “nevirapine tail” during interruptions. We have shown that lack of transport to pick up monthly ARV refills is a common cause of treatment interruption. We will determine the behavioral, biologic and economic impact of monthly transportation assistance in a rural African ARV treatment setting in a 200 person randomized controlled trial.
We propose a randomized controlled trial with a cross over design of monthly transport to clinic concurrent with refill dates and physician visits compared to standard care (no transport provided) among 200 people attending the Mbarara University HIV Clinic in rural southwestern Uganda. With the cross over design, both groups shall receive the intervention of monthly transport assistance for 12 months. We will conduct an economic analysis to determine the maximal justifiable investment for scalable transport intervention strategies.

Aims
Aim 1. Behavioral Outcomes. We will determine the impact of transport assistance on reducing medication event monitored system (MEMS) defined treatment interruptions. Mean adherence, ARV drug possession ratio, and missed/late clinical encounters will be secondary outcomes.

Aim 2. Biologic Outcomes. We will determine the impact of transport assistance on HIV VL (<400 copies/ml).

Aim 3. Economic Outcomes. We will determine the impact of transport assistance on total hours worked per week. Secondary outcomes will be participation in the labor force, household consumption, monetary transfers, hours of school attended per week and hours of child labor per week by children in patients’ households.

Study status

Transport study is closed to enrollment but data analysis is ongoing.

We were able to recruit 149 participants into the study
The study status as at the close of enrollment and follow ups  was as below:

Graduated                       119

Deceased                         13
 
Withdrawn                        1

Lost to follow up               10

Transferred out                6
 

P.I.: David Bangsberg.

       Winnie Muyindike.

Study Coordinator: Allen Kekibiina