Skip to content

Motivation Matters Study

Motivation Matters! Randomized Clinical Trial of Theory Based SMS to Support Treatment as Prevention in High-Risk Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02627365
Acronym
MM
Enrollment
119
Registered
2015-12-10
Start date
2016-01-31
Completion date
2018-08-31
Last updated
2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Keywords

ART, mobile messaging, behaviour, motivation

Brief 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.

Detailed 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).

Interventions

BEHAVIORALIndividualized, interactive short messaging intervention

An Individualized, interactive short messaging intervention reminding study participants to take antiretroviral medication and report any problems.

Sponsors

University of Nairobi
CollaboratorOTHER
Kenya Medical Research Institute
CollaboratorOTHER
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* More than 18 years or emancipated minor * Has access to mobile phone * Self-identifying female sex worker * Willing to receive study SMS messages * HIV-positive (any WHO stage or CD4) * Able to read or have someone else read * ART naïve * Informed consent obtained and signed.

Exclusion criteria

* Plans to move away in next 6 months * Contraindication to ART

Design outcomes

Primary

MeasureTime frameDescription
Plasma HIV-1 viral loadsix monthsThe plasma HIV-1 viral load will be compared between participants in the intervention and in the non-intervention arm.

Countries

Kenya

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026