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Recruiting

NCT Number: NCT06745050

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Partner for Health and Development in Africa

Nairobi, Kenya

Location status: Recruiting

Location contact

Joshua Kimani, MD, MPH

CONTACT

[email protected]

+254 733 719711

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Participants with undetectable viral load at 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kerri Sloan

CONTACT

[email protected]

206 543-4278

Raymond S McClelland, MD

CONTACT

[email protected]

206 543-4278

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Partners for Health and Development in Africa (PHDA)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 20, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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