1. HIV Prevention for Drug-Involved Couples: Gender-Based Approach

2. Presentation will cover: Status and progress of couples-based HIV prevention interventions Connect Two: HIV intervention for drug- using couples (n=282 couples, completed 2010, funded by NIDA) Implications of the findings for HIV prevention for drug-using couples

3. Our “Toolbox” Advances in HIV Prevention: GroupCommunitySocial NetworkIndividualCouples-based Multilevel Structural

4. Evidence-Based HIV Prevention for Couples Most behavioral HIV prevention efforts among heterosexual adults: Target individuals or groups and women more than men Pay little attention to relationship contexts Fail to include both members of the couples

5. HIV Prevention for Couples (2009) 8 behavioral couples-focused HIV prevention efficacy studies conducted in six countries 5 conducted in US and 3 in other countries (Africa and the Caribbean) –None conducted with drug users –Among US studies, only one met CDC criteria for evidence-based model (Project Connect)

6. Project Connect Completed in 2001 (funded by NIMH) 217 couples recruited from primary care settings 30% had a history of drug use Intervention did not address drug use and risks Outcomes: sexual HIV risk-reduction

7. Project Connect is being disseminated in 80 HIV/AIDS Clinics in New York State (funded by NIMH) Connect Dissemination

8. Project Eban Multi-Site HIV prevention study with sero- discordant African American Couples (n=535) (NIMH, completed 2009)

9. Project Connect Two Randomized, controlled clinical trial for young drug-involved HIV negative couples First couples-focused HIV prevention study for drug users 5-year study funded by the National Institute for Drug Abuse (NIDA)

10. Project Connect Two: Aims To examine the efficacy of 7 sessions of relationship- based HIV/STI prevention intervention for heterosexual couples, compared to a 7-session couples-based Wellness Promotion control condition To determine whether 7 sessions of relationship- based HIV prevention intervention is more effective when both members of the couple receive the intervention together than when one member receives it alone

11. Flyers Word-of-Mouth Local Newspapers Family/Adult Shelters Or your partner in or seeking drug treatment? Recruitment

12. Inclusion Criteria for the Couples One member of the couple is between ages 18-40 Both are HIV negative Both identify each other as main, regular partner, boy/girlfriend, spouse, lover Both report they were together for at least 6 months Both intend to remain together for at least 12 months At least one member is seeking or in drug treatment At least one member reported an unprotected act of vaginal or anal intercourse with each other in the prior 90 days

13. Inclusion Criteria At least one partner reported an outside risk: Having had sex with other partners in the prior 90 days OR Having injected drugs in the prior 90 days (shared syringes or cooker) OR Having had a sexually transmitted infection in the prior 90 days

14. Exclusion Criteria Severe intimate partner violence within the relationship in the past year Currently trying to get pregnant

15. Project Connect Two : Design Screened 1616 individuals 865 Eligible individuals (54%) Couple HIV Risk Reduction 7 sessions (95) Individual HIV Risk Reduction 7 sessions (92) Couple Wellness Promotion 7 sessions (95)  Immediately Post- Treatment (IPT)  6-Month Follow-Up  12-Month Follow-Up  Immediately Post- Treatment (IPT)  6-Month Follow-Up  12-Month Follow-Up Baseline 346 Couples (80%) HIV Testing (22 HIV positive) Randomization 282 Couples (82%)  Immediately Post- Treatment (IPT)  6-Month Follow-Up  12-Month Follow-Up

16. Follow-up Rates at IPT, 6-month and 12-month Follow-up

17. Sociodemographics Total (n = 564) Women (n = 282) Men (n = 282) Mean age36 yrs.35 yrs.38 yrs. African American49%45%53% Latino/a26%25%28% Never married45% Married43% High school or GED63%56%71% Employed19%15%23% Homeless26%27%25% In prison or jail (past 90 days)21%15%27% Mean monthly income (SD)$389 ($489)$404 ($539)$374 ($433)

18. Length of Relationship Years (SD)

19. Sexual Behaviors Sexual Behaviors at Baseline: Mean (SD) or percentage Number of acts of intercourse with Study Partner in the past 90 days 44.9 (50.3) Number of unprotected acts of intercourse with Study Partner in the past 90 days 42.0 (49.8) Number of acts of intercourse across All Partners in the past 90 days 48.9 (53.0) Number of unprotected acts of intercourse across All Partners in the past 90 days 44.3 (51.8) Had multiple partners in the past 90 days 32%

20. Sex Trading (past 90 days) %

21. Illicit Drug Use Among 282 Couples (past 30 days)

22. % Injected Drugs Among 282 Couples (past 30 days)

23. % Shared Needles/ Syringes Among 282 Couples (past 30 days) %

24. Social Cognitive Theory and Ecological Framework Sexual & Drug Risk Behavior  Perceived risk-perception  Outcome expectancies  Self-efficacy  Intention/motivation/rewards  Couples’ communication, negotiation, problem solving skills  Sexual pleasure and dysfunction  Couple drug habits, couple dependencies, and commitment  Social support, social network  Male and female gender norms and expectations  Homelessness, access to resources, employment  Community norms Intervention Cognitive Individual Interpersonal & Relationship Environmental Macro Structural Substance Abuse

25. Couples’ perceived risk of HIV (HIV/AIDS, STI knowledge) Motivation to engage in safer sex and drug risk as a couple Couples’ commitment to maintaining a healthy relationship Gender roles and expectations related to sexuality, reproductive health, and safer sex practices Couple’s agency, pleasure and preferences on condom use and safe sex practices (pleasure for both partners) Core Components of the HIV/STI Risk Reduction

26. Reducing drug-related triggers for unsafe sex –Drug use and unwanted sex (forced sex while female partner is high on drugs) –Drug dependency and sex trading (female partner may be forced to sell sex for drugs for her partner and herself) –Use of certain drugs (and alcohol) increases both partners’ expectancies for unprotected sex –Drug use impairs ability to negotiate condom use –Drug dependency increases male sexual dysfunction (ability to sustain an erection) which may impede condom use Core Components of the HIV/STI Risk Reduction

27. Drug use and sharing syringes/needles and HIV: –Meaning of sharing syringes/needles in an intimate relationship (trust, love for each other) and risks associated with sharing –Meaning of refusing to share needles or to be injected by the partner and communication skills on refusal to share syringes/needles –Male partner’s dominance in accessing clean needles for the female partner or attending drug treatment and harm reduction –Maintaining drug treatment as a couple Core Components of the HIV/STI Risk Reduction

28. Skills Building: –Speaker-Listener (communication skills) –Problem-solving skills –Help seeking and social support –Goal setting Core Components of the HIV/STI Risk Reduction

29. Technical skills on condom use and cleaning needles Access to harm reduction and drug treatment Access to social supportive network Referral to services (resources manual) Social network-delivery of effective prevention messages to their family Core Components of the HIV/STI Risk Reduction

30. HIV Risk Reduction Sessions Attendance

31. Primary Outcomes Number of unprotected acts of vaginal and anal intercourse with the study partner across all partners Injection drug use Sharing syringes/needles syringes

32. Average # of Unprotected Acts of Intercourse with the Study Partner ( past 90 days) %

33. Average Number of Unprotected Acts of Intercourse across All Partners (past 90 days) %

34. Average Number of Sexual Partners (past 90 days) %

35. Test Hypothesis #1: Intervention To examine the efficacy of the relationship-based HIV/STI prevention intervention compared to a Wellness Promotion control condition Couple Risk Reduction Individual Risk Reduction Couple Wellness Promotion Randomization vs. Couple Risk Reduction Individual Risk Reduction

36. Test Hypothesis #2: Modality To determine whether the relationship-based prevention intervention is more efficacious when both members of the couple receive the intervention together than when one member receives it alone vs. Couple Wellness Promotion Randomization Couple Risk Reduction Individual Risk Reduction

37. Data Analysis: Multilevel Modeling Multilevel Mixed-Effects Model to analyze longitudinal couple data (i.e., individual [level 1], within a couple [level 2], over time [level 3]) –Used Individual as unit of analysis, identified random effects for couple and time Random-effect parameters accommodate for within-couple dependencies (but allow the variation of individual’s reports within a couple) and repeat measures Multilevel mixed-effects model incorporates random-effect parameters into generalized linear models: –Multilevel mixed-effects Poisson regression for number of unprotected acts of intercourse –Multilevel mixed-effects logistic regression for injecting drugs, sharing needles, and sharing works

38. OverallIPT 6-Month 12-Month With Study Partner Intervention vs. Wellness Promotion 0.70 ** [0.53, 0.92] 0.58** [0.38, 0.88] 0.70* [0.54, 0.92] 0.85 [0.55, 1.32] Modality (Couple Risk vs. Individual Risk) 0.71 * [0.51, 0.97] 0.84 [0.52, 1.35] 0.70* [0.51, 0.96]* 0.59 * [0.35, 0.99] Across All Partners Intervention vs. Wellness Promotion 0.69 ** [0.54, 0.88] 0.59** [0.41, 0.86] 0.69** [0.54, 0.88] 0.81 [0.55, 1.19] Modality (Couple Risk vs. Individual Risk) 0.74 * [0.56, 0.99] 0.89 [0.57, 1.37] 0.74* [0.56, 0.98] 0.62 * [0.39, 0.98] * p<0.05; ** p<0.01 Multilevel Poisson Regression Models for Number of Unprotected Acts of Intercourse (past 90 days) (Incidence rate ratio and 95% confidence intervals)

39. Average Number of Times Injected Drugs (past 30 days)

40. Prevalence of Drug Injection (past 30 days)

41. % of Sharing Needles/syringes (past 30 days)

42. Multilevel Logistic Regression Models for Injecting Drugs, Sharing Needles and Works (past 30 days) (Odds ratio and 95% confidence intervals) OverallIPT 6-Month 12-Month Injected drugs Intervention vs. Wellness Promotion 0.56 † [0.29, 1.08] 0.65 [0.24, 1.79] 0.55 † [0.29, 1.08] 0.47 [0.17, 1.35] Modality (Couple Risk vs. Individual Risk) 0.89 [0.39, 1.99] 0.98 [0.29, 3.33] 0.88 [0.39, 1.98] 0.78 [0.21, 2.93] Shared needles Intervention vs. Wellness Promotion 0.96 [0.34, 2.72] 2.30 [0.46, 11.64] 0.89 [0.31, 2.52] 0.34 [0.06, 1.86] Modality (Couple Risk vs. Individual Risk) 0.28 † [0.07, 1.03] 0.26 [0.04, 1.48] 0.29 † [0.08, 1.11] 0.33 [0.03, 3.26] † p<0.1; * p<0.05; ** p<0.01

43. Conclusion Connect Two is an efficacious behavioral prevention strategy for drug-involved couples Couples-based HIV prevention promoted long-term sexual risk reduction compared to individual risk reduction Reduction in unprotected sex with the main partner and across partners has implications on reducing new infections Couples-based HIV prevention is more cost effective than individual HIV prevention Responsibility for HIV prevention is placed on both members of the couple as active agents of change (couples agency)

44. Conclusion

45. Thank You Louisa Gilbert, PhD Susan Witte, PhD Elwin Wu, PhD Mingway Chang, PhD Robert Remien, PhD Jennifer Hill, PhD, New York University Olivia Copeland Lolita Roy Omi Gray Bright Sarfo Claudette Bannerman Sarah O’Brien Tim Hunt