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

NCT ID: NCT06745050

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2029-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Text message mHealth Evidence-based intervention

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Partners for Health and Development in Africa (PHDA)

UNKNOWN

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Scott McClelland

Professor of Medicine, Epidemiology, Global Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raymond S McClelland, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Partner for Health and Development in Africa

Nairobi, , Kenya

Countries

Kenya

Central Contacts

Kerri Sloan

Role: CONTACT

ksloan3@uw.edu

206 543-4278

Raymond S McClelland, MD

Role: CONTACT

mcclell@u.washington.edu

206 543-4278

Facility Contacts

Joshua Kimani, MD, MPH

Role: primary

kimani@CSRTKenya.org

+254 733 719711

Other Identifiers

R01MH132536-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00021169

Identifier Type: -

Identifier Source: org_study_id