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Clinical Trials/NCT06745050
NCT06745050
Not Yet Recruiting
N/A

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

University of Washington1 site in 1 country350 target enrollmentJanuary 1, 2026

Overview

Phase
N/A
Intervention
Not specified
Conditions
HIV Antiretroviral Therapy (ART) Adherence
Sponsor
University of Washington
Enrollment
350
Locations
1
Primary Endpoint
Participants with undetectable viral load at 6 months
Status
Not Yet Recruiting
Last Updated
7 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2026
End Date
December 31, 2029
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Scott McClelland

Professor of Medicine, Epidemiology, Global Health

University of Washington

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Plans to move away in next 6 months
  • Undetectable viral load at baseline

Outcomes

Primary Outcomes

Participants with undetectable viral load at 6 months

Time Frame: From enrollment to end of study at 6 months

Study Sites (1)

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