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

NCT06745050 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-05-12

No results posted yet for this study

Summary

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.

Conditions

  • HIV Antiretroviral Therapy (ART) Adherence

Interventions

BEHAVIORAL

Text message mHealth Evidence-based intervention

MM! includes three messages per week in month one, then two messages per week for the six-month intervention period. Earlier messages include more informational and motivational content, while later messages include more behavioral skills.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Partners for Health and Development in Africa (PHDA)

    collaborator UNKNOWN

  • University of Washington

    lead OTHER

Principal Investigators

  • Raymond S McClelland, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-30
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06745050 on ClinicalTrials.gov