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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
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This is a two-phase study, consisting of the following plan:
Phase I - This is a pre-test of the feasibility and acceptability of the beta version of a computer-delivered intervention, Motivational Enhancement System for Adherence (MESA), as well as the control intervention Motivational Enhancement System for Health (MESH) at three selected AMTUs. Following analysis of the responses in Phase I and further modification of the intervention, Phase II will be initiated.
Phase II - This is a pilot, randomized, controlled trial (RCT) testing a two-session computer-delivered intervention, MESA, designed to increase motivation for adherence to Highly Active Antiretroviral Therapy (HAART) among youth newly recommended to begin medications, as well as an attention control, MESH, matched for dose and delivery format. Phase II is open to all 15 AMTUs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MESA | Experimental |
| |
| MESH | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Enhancement System for Adherence (MESA) | Behavioral | MESA is designed to increase motivation for adherence to Highly Active Antiretroviral Therapy (HAART) among youth newly recommended to begin medications. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the feasibility and acceptability of the Motivational Enhancement System for Adherence (MESA) among HIV-infected youth newly beginning HAART; and in an attention control condition plus standard care. | 26 months | |
| To compare levels of motivation to adhere and adherence and reductions in HIV-1 viral loads at follow-up among youth randomized to MESA plus standard care versus those randomized to MESH plus standard care. | 26 months |
| Measure | Description | Time Frame |
|---|---|---|
| To compare service utilization rates among youth randomized to MESA plus standard care versus those in an attention control condition plus standard care. | 26 months | |
| To examine self-efficacy for adherence for youth randomized to MESA plus standard care compared to those in an attention control condition plus standard care. |
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Inclusion Criteria:
Phase I & II, all participants
Phase I MESA Participants/Phase II All Participants - Recommended by a health care provider to start HAART for treatment of HIV-1 infection within the 12 weeks prior to protocol screening.
Phase I MESH Participants
- Not recommended by a health care provider to start HAART for treatment of HIV-1 infection.
Exclusion Criteria:
Phase I & II, all participants
Phase II, All Participants Prior participation in the Phase I MESA intervention (Phase I MESH control participants are eligible to participate).
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| Name | Affiliation | Role |
|---|---|---|
| Sylvie Naar-King, PhD | Adolescent Trials Network | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hopsital of Los Angeles | Los Angeles | California | 90027 | United States | ||
| Univ of Califormia at San Francisco |
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| Label | URL |
|---|---|
| ATN Website | View source |
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| Motivational Enhancement System for Health (MESH) | Behavioral | Motivational Enhancement System for Health (MESH) is an attentional control providing information on nutrition and exercise. |
|
| 26 months |
| To assess HAART medication knowledge among youth randomized to MESA plus standard care versus those in an attention control condition plus standard care. | 26 months |
| To assess levels of motivation and self-efficacy for healthy eating and exercise among youth randomized to MESH plus standard care compared to those randomized to MESA plus standard care. | 26 months |
| To examine the levels of nutrition and exercise knowledge among youth randomized to MESH plus standard care compared to those randomized to MESA plus standard care. | 26 months |
| San Francisco |
| California |
| 94143 |
| United States |
| Children's Hosp Natinal Med Center | Washington D.C. | District of Columbia | 20010 | United States |
| Children's Diagnostic and Treatment Center | Fort Lauderdale | Florida | 33316 | United States |
| University of Miami-Jackson Memorial Medical Center | Miami | Florida | 33101 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Stoger Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Mount Sinai Medical Center | New York | New York | 10128 | United States |
| Children's Hospital at Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Children's Hopsital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| St. Jude Childrens Research Hospital | Memphis | Tennessee | 38105 | United States |
| University Pediatric Hospital | San Juan | 00936 | Puerto Rico |
| ID | Term |
|---|---|
| D006262 | Health |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
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