HIV Antiretroviral Therapy (ART) Adherence
Conditions
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.
Interventions
BEHAVIORALText 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.
Sponsors
University of Washington
National Institute of Mental Health (NIMH)
Partners for Health and Development in Africa (PHDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participants with undetectable viral load at 6 months | From enrollment to end of study at 6 months |
Countries
Kenya
Contacts
CONTACTKerri Sloan
CONTACTRaymond S McClelland, MD
PRINCIPAL_INVESTIGATORRaymond S McClelland, MD
University of Washington
Outcome results
None listed