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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH132536-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Partners for Health and Development in Africa (PHDA) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants with undetectable viral load at 6 months | From enrollment to end of study at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kerri Sloan | Contact | 206 543-4278 | ksloan3@uw.edu | |
| Raymond S McClelland, MD | Contact | 206 543-4278 | mcclell@u.washington.edu |
| Name | Affiliation | Role |
|---|---|---|
| Raymond S McClelland, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Partner for Health and Development in Africa | Recruiting | Nairobi | Kenya |
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