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

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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Antiretroviral Therapy (ART) Adherence
• Intervention / Treatment: Behavioral: Text message mHealth Evidence-based intervention

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kerri Sloan; Phone Number: 206 543-4278; Email: ksloan3@uw.edu
• Study Contact Backup: Name: Raymond S McClelland, MD; Phone Number: 206 543-4278; Email: mcclell@u.washington.edu

Study Locations

• Kenya
  • Nairobi, Kenya
    • Recruiting
    • Partner for Health and Development in Africa
    • Contact: Joshua Kimani, MD, MPH; Phone Number: +254 733 719711; Email: kimani@CSRTKenya.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Participants with undetectable viral load at 6 months	From enrollment to end of study at 6 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH); Partners for Health and Development in Africa (PHDA)
• Investigators: Principal Investigator: Raymond S McClelland, MD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00021169; R01MH132536-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No