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Project Connect

Project Connect. The presentation will cover: Overview of SIG The rationale for designing an HIV/STI prevention intervention for couples Project Connect Implications of the findings for other HIV studies with couples (Connect II and Eban) . The Social Intervention Group.

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Project Connect

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  1. Project Connect The presentation will cover: • Overview of SIG • The rationale for designing an HIV/STI prevention intervention for couples • Project Connect • Implications of the findings for other HIV studies with couples (Connect II and Eban)

  2. The Social Intervention Group • Formed in 1990 at the Columbia University School of Social Work as an interdisciplinary applied research center • Our mission is to use behavioral, social sciences, and biomedical research in order to design, test and disseminate innovative intervention and prevention models on HIV, substance abuse and IPV and on these co-occurring problems • Types of applied research conducted • Behavioral Intervention and prevention research • Dissemination and translation of research findings • Health service research to understand access, utilization & barriers to services and cost benefit research

  3. The Social Intervention Group • 35 Full time staff • 70% people of color • 80% women • 6 Faculty • 5-7 Masters students a year • 2-3 Pre-doc students • 2-3 Post-doc fellows • 1-3 Visiting research scientists and faculty • 20 CAB members recruited from community-based organizations, consumers, and policy makers

  4. The Social Intervention Group • International Research (2002) • Mongolia, Kazakhstan, Tajikistan, Uganda, China, Israel

  5. Center for Intervention and Prevention Research on HIV and Drug Abuse • Since April 2001, SIG has housed a training program funded for five years by the National Institute on Drug Abuse • The center supports the next generation of intervention researchers by providing training/mentoring to: • Faculty from social work and other disciplines and departments • Promising young scholars/Pre- and Post-doc graduate students in field placement • Sponsors interdisciplinary seminars, workshops on the science of intervention

  6. The Paradigm Shift in Intervention Research • Emphasizes the multicultural competencies of the researchers • Does not view researchers as the sole authority in the research design • Community members, study participants, and agency personnel are involved as partners in all stages of the research. Participants’ expertise in the study’s topic is recognized

  7. SIG’s Research Process Scientific Advisory Community Advisory Board Community Consumers Other Researchers Agency Study Site

  8. SIG’s Research Process Scientific Advisory Community Advisory Board Community Consumers Other Researchers SIG Agency Study Site

  9. Project Connect:Relationship-Based HIV/STI Intervention for Heterosexual Couples Social Intervention GroupColumbia University School of Social Workhttp://www.columbia.edu/cu/ssw/sig/

  10. Project Connect • Randomized, controlled clinical trial • 4-year study funded by the National Institute of Mental Health (NIMH, R01AI40883) • Carried out 1997 – 2002

  11. HIV/AIDS Among Women in the US • Women now make up an increasingly larger proportion of the AIDS epidemic, rising from 14% of adults living with AIDS in 1992 to 22% of adults living with AIDS in 2003.

  12. Science of HIV/STI Interventions for Women in Long-term Relationships • While some progress has been made in the science of HIV/STI prevention interventions for women, couple-based HIV/STI prevention interventions are still in their early stages • Most couple-based HIV/STI interventions have been conducted abroad, with only a few studies conducted in the US (El-Bassel et al., Harvey et al.), • Studies done outside the US have demonstrated that providing intervention sessions conjointly to both members of a dyad is efficacious in promoting HIV counseling and testing and increasing condom use (Allen et al.; Pedian et al.; Musaba et al.; Deschamps et al.)

  13. Science of HIV/STI Interventions for Women in Long-term Relationships A couple-based relationship approach to HIV/STI prevention • Allows a more realistic appraisal of the couple’s risks for HIV transmission • Addresses the context of gender and power in the relationship, intimacy, love, and closeness and how they are related to HIV risk among couples • Provides a supportive environment that enables intimate partners to feel safe disclosing highly personal information (extra-dyadic relationships, STIs, etc.) and to learn effective couple communication and negotiation of condom use together.

  14. Project Connect: (217 couples) • Six sessions of relationship-based HIV/STI prevention intervention provided conjointly to couples (n = 81 couples) • Six sessions of relationship-based HIV/STI prevention intervention provided to women without their partners (n = 73 couples) • One HIV/STI information session provided to women without their partners (n = 63 couples)

  15. Project Connect: Design Screened 2416 388 eligible women (16%) Baseline 217 Couples (56%) Randomization Couple Sessions Woman-Alone Sessions Education/ControlSession 3-Month Follow-Up ♀ and ♂ 3-Month Follow-Up ♀ and ♂ 3-Month Follow-Up ♀ and ♂ 12-Month Follow-Up ♀only 12-Month Follow-Up ♀only 12-Month Follow-Up ♀only

  16. Follow-up Rates • 84% for 3 month follow-up • 80% for 12 month follow-up

  17. Randomization Couple Woman-Alone Education Couple Woman-Alone Education vs. Project Connect: Aim # I • To examine the efficacy of the relationship-based HIV/STI prevention intervention

  18. Randomization Couple Woman-Alone Education Couple Woman-Alone Project Connect: Aim # 2 • To determine whether the relationship-based prevention intervention is more effective when both members of the couple receive the intervention together than when women receive it alone vs.

  19. Project Connect • Study site: • Hospital-based outpatient clinics in New York City • Community catchment area is predominantly low-income, minority (55% Latino, 35% African American) with a high prevalence of HIV

  20. Inclusion Criteria for Women • Between 18 and 55 years old • Has a main, regular sexual partner (“study partner”) with whom she has been involved for at least 6 months • Is confident that she will stay with this partner for at least one year • Has had sex with this partner in the prior 30 days • Has not used condoms consistently with this partner in the prior 90 days • Reports no life-threatening abuse (per CTS2) by this partner in the prior 6 months

  21. Inclusion Criteria for Women: Partner Risk • Woman reports that she knows or suspects that her main, regular sexual partner (study partner): • had sex with other men or women (prior 90 days) • contracted or had symptoms of an STI (prior 90 days) • injected drugs (prior 90 days) • is living with HIV

  22. Recruitment Protocol • Women approached and screened for study • If eligible, she is presented with a choice of ways to engage her male partner: • We provide her with an official invitation that she can give him as she invites him herself • Project Connect staff will call to invite him and answer questions • Some combination of the above

  23. Sociodemographics

  24. Risk Characteristics(at Baseline)

  25. Theoretical Background for theRelationship-Based Intervention • Cognitive/Behavior Theories • Feminist Theory/Gender Roles • Ecological Framework • Marital and Family Therapy

  26. Conceptual Framework • Mediators • Ontogenic Factors • Condom use self efficacy • Condom use intention • Condom use expectancy • Microsystem Factors • Couple’s sexual communication • Couple’s condom self efficacy • Relationship dependencies • Couple’s problem solving skills • Exosystem Factors • Social support • Help seeking • Macrosystem Factors • Gender roles and expectations • Safer sex power dynamic • Moderators • Gender, age • HIV status • Alcohol/drug use • Baseline data • Psychological distress • Relationship satisfaction • Length of relationship • Sexual dysfunction • Outcomes • # unprotected sex acts • % protected sex acts • # STI symptoms

  27. Session 1: Couples • Enhance motivation of participants • Normalize need for HIV prevention for couples • Reduce anxiety, misperceptions, or stigma • Address concrete barriers to attendance • Sign contract of commitment

  28. Session 2: Couples • Review pros and cons of participation, and clarify roles and expectations • Increase perceived vulnerability • HIV/STI information • Identify personal HIV and STI risks • Identify positive reasons to stay healthy • Discuss and promote joint HIV testing • Learn safer sex communication skills: Speaker/Listener technique

  29. Session 3: Couples • Identify HIV risks among steady partners • Impact of HIV on family and community • Myths and facts about partner fidelity and honesty • Explore individual and couple strengths related to safer sex practices and mutual protection • Explore gender differences related to sexuality • Introduce safer sex as a sign of love, caring and joint responsibility

  30. Session 4: Couples • Safer sex decision-making among couples • Unwritten rules about sex and power dynamics within the relationship • Decision-making process for condom use • Discuss male and female anatomy, and male and female sexual health issues • Identify safest condom and lubricant types • Demonstrate and practice male and female condom use • Introduce “menu” of safer sex options and ordering

  31. Session 5: Couples • Identify triggers for unprotected sex • Identify and practice steps of problem-solving related to HIV risk reduction • Review HIV joint testing as a prevention strategy • Discuss how the couple can share HIV prevention knowledge and skills with their family, friends and community

  32. Session 6: Couples • Identify relapse to unsafe sex situations • Practice skills to deal with relapse: self talk, speaker/listener, problem-solving • Maintaining a mutually-satisfying and safe relationship; renewing couple commitment • Identifying ways to make safer sex more fun as a reward for each other • Delivery of effective prevention messages • Graduation: presentation of certificates

  33. Facilitator Qualifications • Social work or public health degree • All sessions delivered by female facilitators • Two–hour intervention sessions provided by one female facilitator • Facilitators were trained to conduct intervention sessions in all three arms of the study

  34. Facilitator QA • Weekly facilitator meetings • Review of weekly tape selection bringing highlights to meeting • Expert consultation/supervision with Ackerman Institute for the Family Executive Director, Peter Steinglass

  35. Baseline 3-Month Follow-Up # Unprotected Sex: Baseline & 3-Month Follow-Up Couple Woman-Alone Education Unprotected Sex in Prior 90 days (#)

  36. Baseline 3-Month Follow-Up % Protected Sex: Baseline & 3-Month Follow-Up Couple Woman-Alone Education Protected Sex in Prior 90 days (%)

  37. Baseline 3-Month Follow-Up # STI Symptoms: Baseline & 3-Month Follow-Up Couple Woman-Alone Education STD Symptoms in Prior 90 days (#)

  38. Data Analysis: Treatment Effects • Intent-to-treat approach • Random-effect models which accommodates for within couple dependencies. The random effects models were incorporated into linear regression models • In order to estimate treatment effects with greater efficiency, we adjusted for baseline values, gender, and HIV status in order to eliminate the association between the outcomes and these variables • Multiple imputation to handle missing data

  39. Regression Analysis with Random Effects Estimates Note: All outcome variables refer to self-report about the 90-day period before assessment. SE=standard error. *p < .05

  40. Baseline 12-Month Follow-Up # Unprotected Sex: Baseline & 12-Month Follow-Up Couple Woman-Alone Education Unprotected Sex in Prior 90 days (#)

  41. Baseline 12-Month Follow-Up % Protected Sex: Baseline & 12-Month Follow-Up Couple Woman-Alone Education Protected Sex in Prior 90 days (%)

  42. Baseline 12-Month Follow-Up 100% Protected Sex: Baseline & 12-Month Follow-Up Couple Woman-Alone Education 100% Protected Sex in Prior 90 days (%)

  43. Baseline 12-Month Follow-Up # STI Symptoms: Baseline & 12-Month Follow-Up Couple Woman-Alone Education STI Symptoms in Prior 90 days (#)

  44. Data Analysis: Treatment Effects • We used two approaches to analyze the data • Intent to treat • Complete dose analysis (using subset of “completers,” those who attended all six sessions and received a complete dose of the intervention) • Propensity score matching for dose analysis to identify matches for the completers from those in the control group • Pre-treatment variables were: age, ethnicity, homelessness, financial dependencies, injection drug use by the study partner, safe sex communication, self efficacy, problem solving, relationship satisfaction.

  45. Data Analysis: Treatment Effects for 12 Months • The unit of analysis is the woman because data were only collected for men at 3 months • Ordinary least squares (OSL) regression for continuous variables and logistic regression for binary • In order to create a treatment effects with a smaller standard of errors, we adjusted for baseline, gender, and HIV status, in order to eliminate the association between the outcomes and these variables • Multiple imputation to handle missing data

  46. Results: Intervention Effects Note: All regression models included adjustment for the following covariates: HIV status, pregnancy intention, and the baseline measurement of the study outcome. *P < .1; **p < .05

  47. Results: Modality Effects Note: All regression models included adjustment for the following covariates: HIV status, pregnancy intention, and the baseline measurement of the study outcome.

  48. Conclusions from Project Connect • Recruitment and retention of African American and or Latino couples in HIV prevention intervention research is feasible • The relationship-based HIV/STI prevention intervention for African American and Latina women and their male sexual partners is effective in reducing HIV/STI risk behaviors • Behavioral change on HIV risk was maintained over time (12 months).

  49. Conclusions from Project Connect • Differences in the efficacy of the intervention as a function of modality (i.e., couples vs. woman-alone) was not significant • The study provides two alternative effective modalities to reduce HIV risk among women and their main sexual partners • Relationship-based HIV interventions can be delivered to women alone, if the partner is aware of and willing to be engaged in the intervention through the female partner.

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