Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02627365 |
Other study ID # |
STUDY00000394 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 2016 |
Est. completion date |
August 2018 |
Study information
Verified date |
November 2020 |
Source |
University of Washington |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The study aims to develop and evaluate the efficacy and causal mechanisms of an interactive
SMS intervention to optimize individual health and secondary HIV prevention benefits of ART
in HIV-positive FSWs.
Description:
Antiretroviral therapy (ART) is highly effective at reducing the infectiousness of
HIV-positive people, and is considered the cornerstone of all new HIV prevention approaches.
A critical question is how to harness the potency of ART to reduce transmission from female
sex workers (FSWs), a key population that has been central to HIV transmission in Africa for
more than 25 years. In high prevalence countries like Kenya, FSWs represent about 1% of the
population, yet contribute to one in seven (14%) new HIV infections. Targeting treatment as
prevention (TasP) to FSWs could efficiently reduce HIV transmission on a population level.
Effective TasP will require higher levels of ART adherence than those achieved in typical
treatment programs. The rapid spread of mobile technology in Africa provides unique
opportunities for mobile health (mHealth) interventions, which have been shown to be
acceptable to providers and patients, and can improve ART adherence and suppression of plasma
HIV viral load.
The ability of mobile (SMS) interventions to support ART adherence in key populations like
FSWs and unique clinical scenarios such as TasP has yet to be evaluated. The investigators
will answer these fundamental questions by addressing the following aims: 1) To use a
qualitative rapid assessment and development approach to craft a theory-based,
individualized, interactive SMS intervention, grounded in the Theory of Information,
Motivation, and Behavior (IMB), to support ART adherence in HIV-positive FSWs, 2) To compare
individualized, interactive SMS to standard care in achieving undetectable HIV VL 6 months
post ART initiation in a randomized controlled trial (RCT) with 210 FSWs and 3) To administer
an adaptation of the LifeWindows Information - Motivation - Behavioral Skills ART Adherence
Questionnaire (LW-IMB-AAQ) to understand the mechanism of our SMS intervention's effect by
comparing perceptions of support and motivation to adhere to ART in FSWs who received the
intervention versus standard care.
Our overarching goal is to develop and evaluate the efficacy and causal mechanisms of an
interactive SMS intervention to optimize individual health and secondary HIV prevention
benefits of ART in HIV-positive FSWs. The aims of this project proceed sequentially from
developmental (Aim 1) through implementation of the intervention (Aim 2) to evaluation of the
fit with the behavioral model (Aim 3).