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

NCT06745050 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY00021169R01MH132536-01A1
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Antiretroviral Therapy (ART) Adherence

Outcome Measures

Primary Outcomes (1)

• Participants with undetectable viral load at 6 months

  From enrollment to end of study at 6 months

Study Arms (2)

MM! Intervention

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

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.

Interventions

Text message mHealth Evidence-based intervention BEHAVIORAL

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.

MM! Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator
• Partners for Health and Development in Africa (PHDA): collaborator

Study Sites (1)

Partner for Health and Development in Africa

Nairobi, Kenya

Location

Study Officials

• Raymond S McClelland, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerri Sloan

CONTACT

206 543-4278; ksloan3@uw.edu

Raymond S McClelland, MD

CONTACT

206 543-4278; mcclell@u.washington.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Epidemiology, Global Health

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)