Hybrid Type-1 Effectiveness-Implementation Trial of Motivation Matters!

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Washington

About this trial

The goal of this clinical trial is to learn if an interactive mHealth intervention will be effective in helping HIV-positive women in high-burden settings who are initiating antiretroviral therapy (ART) take their ART regularly as prescribed, effectively reducing their viral load. The main question it aims to answer is:

\- Compared to standard of care, will Motivation Matters! (MM!) be significantly more effective at achieving undetectable viral load in women with HIV by month six.

Researchers will compare the undetectable HIV viral load in women who receive individualized text messages (intervention group) in addition to standard care to those who receive standard care alone (control group).

Participants in the intervention group will receive three messages per week in month one, then two messages per week for the six-month intervention period. Participants will be asked to send a brief, standardized reply to each message, indicating that they are doing well or that they have a question or problem. Regardless of study arm, women will receive ART and counseling consistent with Kenyan guidelines.

Eligibility criteria

Qualifiers

Age >18

Transactional sex in past 12 months

HIV-positive

Not currently on ART

Disqualifiers

Plans to move away in next 6 months

Undetectable viral load at baseline

Pregnant

Trial design

Treatments tested in this trial

  • Text message mHealth Evidence-based intervention

Treatment groups

350 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Washington

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Partners for Health and Development in Africa (PHDA)

Collaborator