Hybrid Type-1 Effectiveness-Implementation Trial of Motivation Matters!
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Text message mHealth Evidence-based intervention.
- Who it may be relevant to
- Registry conditions: HIV Antiretroviral Therapy (ART) Adherence. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kenya
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Participants with undetectable viral load at 6 months [Time frame: From enrollment to end of study at 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Kenya · 1 center
- Partner for Health and Development in Africa — Nairobi
Identifiers
NCT: NCT06745050 · STUDY00021169 · R01MH132536-01A1