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Hybrid Type-1 Effectiveness-Implementation Trial of Motivation Matters! A Theory-Based mHealth Intervention to Support Early Antiretroviral Adherence in HIV+ African Women Who Engage in Sex Work

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>18

• Transactional sex in past 12 months

• HIV-positive

• Not currently on ART

• Enrolled in one of the Sex Workers Outreach Program clinics

• Has access to mobile phone

• Willing to receive study text messages

• Able to read or have someone else read

Locations
Other Locations
Kenya
Partner for Health and Development in Africa
RECRUITING
Nairobi
Contact Information
Primary
Kerri Sloan
ksloan3@uw.edu
206 543-4278
Backup
Raymond S McClelland, MD
mcclell@u.washington.edu
206 543-4278
Time Frame
Start Date: 2026-03-30
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 350
Treatments
Experimental: MM! Intervention
Participants in the MM! arm will receive standard care plus the individualized, interactive text message intervention. MM! includes three messages per week in month one, then two messages per week for the six-month intervention period. Messages are personalized based on participants' preferred name, language, religion, having children, and preferred message delivery time. Participants are asked to send a brief, standardized reply to each message, indicating that they are doing well or that they have a question or problem.
No_intervention: Standard Care
Participants in the control arm will receive standard care according to Kenyan guidelines, including clinic-based adherence education and counseling. This includes clinic-based ART adherence education and counseling provided by nurses specializing in HIV care.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Mental Health (NIMH), Partners for Health and Development in Africa (PHDA)
Leads: University of Washington

This content was sourced from clinicaltrials.gov