We will iteratively adapt and modify the NC woman-focused intervention (Women's CoOp), including the field manual and instrumentation, to focus on pregnant African-American women who abuse crack, are currently in substance abuse treatment, and are at risk for HIV or are HIV positive. We then will test the newly developed intervention in a Stage IB pilot-sized randomized clinical trial (RCT) in a traditional substance abuse treatment clinic to determine (a) feasibility; (b) relative efficacy compared with substance abuse treatment-as-usual (TAU), across several domains of functioning (e.g., substance use, HIV risk behaviors); and (c) the intervention's potential mechanisms of action.
The specific aims of this Stage IA/B study are as follows:
Aim 1. To adapt the culturally specific, manualized woman-focused intervention to specifically address issues of pregnancy and substance abuse, relationships with men, social support, parenting, HIV status, living with HIV, antiretroviral (ARV) treatment, and HIV risk-reduction methods for pregnant and postpartum women.
Aim 2. To compare the relative efficacy of the woman-focused intervention for pregnant women relative to standard substance abuse treatment to sustain reductions in substance abuse and sexual risk behaviors, maintain retention in drug treatment, reduce violence, and improve prenatal care and ARV treatment adherence (as needed) at 3- and 6-month follow-up.
Aim 3. To explore the intervention's potential mechanisms of action (e.g., by examining the mediating effects of changes in knowledge about HIV risk behaviors, psychological distress, readiness for change) and moderating factors (e.g., HIV status, age, stage of pregnancy, relationships with men) that may influence response to the treatment.
Primary Outcome Measures:
- To compare the relative efficacy of the woman-focused intervention in reductions in substance abuse and sexual risk behaviors, maintain retention in drug treatment, reduce violence, and improve prenatal care and ARV treatment adherence (as needed). [ Time Frame: 3- and 6-month follow-up ]
Secondary Outcome Measures:
- To explore the intervention's potential mechanisms of action and moderating factors that may influence response to the treatment. [ Time Frame: at 6 months ]
| Estimated Enrollment: |
100 |
| Study Start Date: |
June 2007 |
| Estimated Study Completion Date: |
August 2008 |
APPROACH During Stage 1A, the team will conduct a series of separate focus groups with an expert panel (including researchers, clinicians, and service providers); our Community Advisory Board; HIV+, substance-using, postpartum women; and HIV-, substance-using, postpartum women. We will first inquire about how we can adapt the existing measures in the instrumentation, adapt the intervention to address issues of substance-using women who are pregnant, and determine the fidelity of its delivery. After this first set of focus groups, the Woman-Focused manual, measures, and intervention will be revised to reflect new adaptations. Then the second set of focus groups with the same members will be conducted for review of these materials and fidelity measures. Feedback will be solicited to verify our adaptations and then it will be pretested to further refine and finalize the manual and measures.
During Stage 1B, we plan to recruit 100 women from a large community-based treatment facility in Raleigh-Durham. We will market the study through a brochure as women enter the treatment program. We will also utilize existing outreach efforts for substance abusers at risk for HIV. Women who are eligible and consent to participate in the study will give a urine sample to assess drug use and take part in a 1½ hour ACASI interview. Topics will include demographics, drug use, substance abuse treatment, physical health, sexual behavior, mental health, employment history, and criminal history. Once they have completed the interview, the women will be randomly assigned to either the women's intervention condition or a treatment as usual condition. Once randomized, women in the woman-focused intervention will be asked to complete four one-hour intervention sessions within a month which will include a personalized assessment and a personal action plan. As part of the second session, woman-focused intervention participants will be offered HIV testing. Women in the TAU condition will receive the traditional substance abuse treatment services. Women in both groups will also be assessed at 3-month and 6-month follow-up. Measures will include behavioral outcomes, satisfaction with the intervention, and services received.
Purpose
