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HIV Center Grand Rounds 18 March 2010 Elwin Wu Columbia University School of Social Work

*. Toward a Couple-Based Intervention for Black Men who Have Sex With Men at Risk for HIV/ STI Transmission. HIV Center Grand Rounds 18 March 2010 Elwin Wu Columbia University School of Social Work http://www.socialwork.columbia.edu/sig.

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HIV Center Grand Rounds 18 March 2010 Elwin Wu Columbia University School of Social Work

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  1. *

  2. Toward a Couple-Based Interventionfor Black Men who Have Sex With Men at Risk for HIV/STI Transmission HIV Center Grand Rounds18 March 2010 Elwin Wu Columbia University School of Social Work http://www.socialwork.columbia.edu/sig

  3. Towards Couple-Based Sexual Risk Reduction for Men who Have Sex With Men (MSM)… • Building upon the Social Intervention Group’s (SIG’s) experience in innovation with respect to HIV prevention and intervention… • Project Connect • Project Eban • Project Connect Two • Dissemination of Connect

  4. Targeting an At-Risk Population:“Methamphetamine-Involved, Black MSM couples” METH-Involved MSM African American EstablishedRelationship

  5. Connect With Pride:Objectives • Primary Aims: • To adapt an existing relationship-based HIV/STI preventive intervention (“Connect”) and revise/refine it for methamphetamine-involved, Black MSM couples. • To obtain preliminary evidence establishing the potential promise regarding the efficacy of the revised intervention • Secondary Aim: • To enhance the feasibility of future, larger-scale randomized clinical trials (RCTs) testing the efficacy of the revised intervention

  6. Target Population:“Methamphetamine-Involved, Black MSM couples” • Main Inclusion Criteria—Men who: • Report having a male “main partner” operationalized as: • a male with whom he has had an ongoing sexual relationship over the prior 6 months, and • a male with whom the participant has an emotional relationship/bond more than any person; • Self-identify as African American/Black*; • Report using methamphetamine at least 1 time in past 60 days*; • Report at least 1 unprotected act of anal intercourse in the prior 60 days with a male who is not the main partner*; and • Identify each other as their main partner *or has male main partner who meets this criterion

  7. Formative Work:Adaptation • Enrolled 8 couples from the target population who participated/returned over a series of 6 focus group: • Provide data on etiological and phenomenological issues • Feedback and suggestions on revising content/activities • Informed feasibility and safety/ethical issues • Recruitment • Community Input: • Focus group with service providers • Program Review Panel • Community Advisory Board QualitativeData/Findings Wu et al. (in press). Adaptation of a couple-based HIV intervention for methamphetamine-involved African American men who have sex with men. Open AIDS Journal.

  8. Vicious Cycles Issues affecting the relationship Methamphetamineuse Meth use↕HIV risk Physiological & psychological sequelae Arguments

  9. METH, HIV, & Black MSM:Analyzing/Incorporating Experiences and Worldviews Personal factors unique to each MSM partners’s developmental history as well as the individual factors posited by SCT to affect risk and protective behaviors Interactional and structural factors that are part of the immediate intimate relationship context in which sexual activity and risk and protective behaviors occur Risk and protective factors that impinge upon the immediate setting by acting as external stressors or buffers on the likelihood of engaging in risky behavior Broad cultural values and belief systems that shape and interact with all of the other analytical levels • Relationship-Oriented Ecological Perspective: targets multiple levels of key individual, relational, and contextual factors that play a role in risk behavior|reduction among intimate partners Macrosystem Exosystem Microsystem Ontogenic • HIV/STI knowledge • Perceived threat of HIV/STIs • Race/ethnicity: HIV, sexual identity • Condom use self-efficacy • Condom use outcome expectancies • Condom use intentions • METH use outcome expectancies • Sex and METH/drug use culture among MSM • Anti-racist and anti-heteronormative perspective (as opposed to non-racist and non-heteronormative ideologies) • Race-conscious (vs. “race- or color-blind”) • Also contrast to presuming congruent ideology (e.g., Afrocentric paradigm) • Affirmation (vs. acceptance) of different sexual identities • Couple condom negotiation-efficacy • Couple sexual communication skills • Couple sexual satisfaction • Couple sexual decision-making power • Race/ethnicity and the relationship w/MSM partner • Impact of METH use and sexual risk on relationship • Social support for risk reduction • Peers/community and race/ethnicity and sexual identity • Peer norms about the threat of HIV • Peer norms about safer sex/condom use • Peer norms about meth

  10. Theoretical Framework • Social Cognitive Theory: identifies/specifies the mediators or intervention’s targets of change • Information/Knowledge: accurate appraisal of risks & risk behavior • Outcome Expectancies: perceived costs/benefits of behaviors of meth use & sexual risk behavior(s) • Impact of the relationship as well as impact on relationship • Social and Self-Regulatory Skills: abilities to recognize triggers & enact risk reduction, including reinforcement • Emphasis on couple-based regulatory skills (e.g., communication, joint problem-solving/reinforcement) • Self-Efficacy: belief in the ability to negotiate HIV risk reduction • Emphasis on self-efficacy w/partner as well as of the couple • Social Support: social influences that increase or decrease risk behaviors, as well as reciprocal effects

  11. Session 0 1 2 ... 6 • Review of last session • HIV/STI 101 • Personal vulnerability • Speaker/listener intro • Goal-setting • Review of last session • Myth/facts @ HIV/STIs • Alternatives to unsafe sex … • Recap & review • Social support network map • Protecting ourselves and protecting our relationship … • Relapse prevention & contingency planning • Speaker/listener practice • Goal-setting • Speaker/listener review • Condom use skills • Goal-setting … • Relapse prevention & contingency planning • Rewarding behaviors, ourselves, & relationship SCT Construct • Taking control of life • Communicating about sex … • Relapse prevention & contingency planning • Speaker/listener intro • Speaker/listener practice • Communicating about sex • Commitment to relationship … • Social support network map • Relapse prevention & contingency planning Revising the Existing Ix:The Starting Point Information • Purpose Outcome Expectancies • Pros/cons of participating Revise Social & Self-Regulatory Skills • Commitment contract Self-Efficacy • Overcoming barriers to participating Social Support • Couple-based approach

  12. Session SCT Construct 11

  13. Pilot Test of Connect With Pride Recruitment& Screening Pre-Test(“Baseline”) InterventionDelivery 2 months Post-Test(“Follow-Up”) • Design: • Recruit 30 METH-involved, Black MSM couples and use a pre-/post-test design to “test” the intervention • Actual: • Recruitment started November 2009 and stopped in April 2010 • Enrolled 34 couples (68 individuals) • 28 of 34 (82%) couples completed all 7 sessions of the intervention • Follow-up assessment completed with 65 participants (96% retention), with at least 1 partner from 100% of the couples

  14. Pilot Test: Measures a Combined receptive and insertive anal intercourse (AI) b At follow-up, if participant had broken up with main partner that was identified at baseline, used “replacement” main partner • Primary Outcomes: Sexual risk over prior 2 months • # of [male] sexual partners • # of episodes of unprotected AIa with main partnerb • % of AI episodesa with main partnerb that were condom-protected • Secondary Outcomes: Drug use over prior 2 months • Frequency of METH use • Frequency of illicit drug use • # of different types of illicit drugs used • Additional Measures: • Sociodemographics (e.g., age, income, education, race/ethnicity) • HIV status Feasibility

  15. Pilot Test: Analyses € ↕ ‚ • Hypothesis Testing: Participants will engage is less sexual risk behavior following receipt of the couples-based intervention • Need to consider non-independence of measures • Level 2: Individual(s) who provide repeated measures • Level 3: Couple(s) consisting of pairs of individuals (reporting on behaviors with each other) • Generalized Linear Mixed Models (GLMM) • Level 2 and Level 3 nesting treated as random effects • Time treated as a fixed effect (0 = baseline, 1 = follow-up) • Inference based upon the coefficient and standard error for the time term (and associated p-value) • Also tested hypotheses for drug use (secondary outcomes) in an analogous manner   Participant Time Time 0 1 X X   0 1 X X X X 0 1 0 1

  16. Pilot Test: Baseline Characteristics(N = 68 individuals) Variables Distribution < x > = 41.5 ( SD = 8.7) Age (yrs.) Employed n = 8 (12%) Has ≥HS Diploma/ GED n = 57 (84%) Income over past 12 mos. < x > = 12.6 ( SD = 9.9) ( × $1000) Race African American/Black n = 62 (91%) Latino n = 5 (7%) Mixed n = 1 (2%) HIV - Positive n = 64 (94%) Used METH in past 2 mos. n = 53 (78%)

  17. Pilot Test Results: Sexual Risk Measures # Sexual Partners # Unprotected AI % Protected AI Notes: Graphs display means, with associated standard errors indicated by the rising stem BL = Baseline (N = 68) FU = Follow-Up (N = 65)

  18. Hypothesis Testing: Sexual Risk # Sexual Partners # Unprotected AI % Protected AI Time - 2.84 *** ( 0.70) - 11.42*** (2.07) 0.54 *** (0.06) Age - 0.08 † (0.05) - 0.34* (0.16) 0.005 (0.004) (yrs.) Employed - 0.53 (1.19) - 2.42 (3.96) 0.04 (0.09) Has HS diploma/ GED - 1.32 (1.04) 0.78 (3.41) - 0.02 (0.08) Annual income 0.04 (0.04) - 0.06 (0.13) - 0.005 (0.003) ( × $1000) Is Black/African 0.76 (1.67) 5.05 (5.44) - 0.0003 (0.13) American Is HIV - positive - 0.004 (1.64) 5.24 (5.48) - 0.29* (0.13) Used METH 2 mos. 1.25 (0. 86) - 3.86 (2.84) - 0.0005 (0.06) prior to enrollment †p < .10; *p < .05; **p < .01; ***p < .001

  19. Pilot Test Results: Drug Use Measures Illicit Drug Use Freq. # Types of Illicit Drugs Used METH Use Freq. Frequency Scale 0 = Never 1 = Less than once a month 2 = Once a month 3 = 2 or 3 days a month 4 = Once a week 5 = 2 or 3 days a week 6 = 4 to 6 days a week 7 = Every Day Notes: Graphs display means, with associated standard errors indicated by the rising stem BL = Baseline (N = 68) FU = Follow-Up (N = 65)

  20. Hypothesis Testing: Drug Use Illicit Drug # Types of Illicit Use Freq. Drugs Used METH Use Freq. Time - 1.85*** (0.28) - 0.31** (0.10) - 0.68** (0.26) Age - 0.04 † (0.02) - 0.01 (0.01) - 0.002 (0.02) (yrs.) Employed - 0.25 (0.68) - 0.30 † (0.16) - 0.38 (0.45) Has HS diploma/ GED 0.26 (0.57) - 0.03 (0.14) - 0.42 (0.39) Annual income 0.01 (0.02) 0.002 (0.005) - 0.01 (0.01) ( × $1000) Is Black/African 1.17 (0.86) 0.52 * (0.23) 1.07 † (0.60) American Is HIV - positive 1.40 (0.89) 0.13 (0.22) - 0.17 (0.60) †p < .10; *p < .05; **p < .01; ***p < .001

  21. Lessons Learned • A couple-based approach to behavioral HIV prevention for methamphetamine-involved, Black MSM couples is • Promising in reducing sexual risk • Promising in reducing METH/drug use • Feasible and safe • Additional aspects: • Methamphetamine → Other drugs • Polydrug use • HIV transmission risk among users of drugs other than METH • Use of female facilitator(s) • Importance of affirming the worth, dignity, and rights of those who are stigmatized, disenfranchised, and/or isolated • Especially for those as the nexus of multiple categories

  22. Next Step(s) • Dissemination of [additional] findings from developmental and pilot test activities • Advance the rigor of efficacy testing of the intervention by addressing key limitations: • No comparison/control group (↔ random assignment) • Timecourse/sustainability • Biological assay for STIs • Sample size • Statistical power (also for moderators and mediators) • Generalizability “Dose” Analyses

  23. Thank you Nabila El-Bassel L. Don McVinney Robert Remien CDC Leona Hess Yves-Michel Fontaine Dale Frett Jordan White Community collaborators/colleagues Study participants

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  25. Target Population: MSM • MSM are actually losing ground in the fight to prevent HIV transmission! • New York City is an HIV epicenter • Male-to-male sexual contact represents thelargest transmission category in the US(CDC, 2008) • 51% of all HIV/AIDS diagnoses in 2006 • 72% of male HIV/AIDS diagnoses in 2006 • Roughly 5 times that of IDU for men • 53% of cumulative HIV/AIDS cases to date • 68% of cumulative male HIV/AIDS cases to date Back Figure adapted from El-Sadr et al. (2010) AIDS in America—Forgotten but Not Gone. NEJM, published at www.nejm.org on February 10, 2010 (10.1056/NEJMp1000069). Figure adapted from Estimates of New HIV Infections in the United States, CDC HIV/AIDS Facts, August 2008 Figure adapted from Hall et al. (2008) Estimation of HIV incidence in the United States. JAMA, 300(5), 520-529.

  26. Need another reason for renewed or new HIV prevention efforts for MSM? • Among “best” or “promising” interventions in 2009 Compendium of Evidence-Based HIV Prevention Interventions published by the CDC: • Heterosexual adults: 32 • High-risk youth: 17 • Drug users: 15 • MSM: 14 Back

  27. Target Population: MSM • African Americans are disproportionatelyaffected by HIV/AIDS in the U.S. • Represent ~50% of new infections (CDC, 2008) • 33% of MSM living with HIV/AIDS are African American (CDC, 2008) • 56% of African Americans living withHIV/AIDS are MSM (CDC, 2008) • In NY(NYCDOHMH) • 1 in 70 New Yorkers is infected with HIV • 1 in 40 African Americans. • 1 in 25 men living in Manhattan. • 1 in 12 black men age 40-49 years. • 1 in 10 men who have sex with men. • 1 in 8 injection drug users. • 1 in 5 black men age 40-49 in Manhattan African American Back Figure adapted from Hall et al. (2008). Estimation of HIV incidence in the United States. JAMA, 300(5), 520-529. Table adapted from Hall et al. (2008). Estimation of HIV incidence in the United States. JAMA, 300(5), 520-529.

  28. Target Population: MSM • MSM in more established relationships may be at elevated risk for HIV transmission • ~1.5 times as likely to have unprotectedanal sex w/main vs. casual partner (Sanchez et al., 2006) • ~2.0 times as likely to have unprotected anal sex with HIV-positive partner if the partner isa main partner vs. casual partner (Sanchez et al., 2006) • Majority of HIV transmissions among MSMare from main sex partners EstablishedRelationship Back Table adapted from Sanchez et al. (2006). Human Immunodeficiency Virus (HIV) risk, prevention, and testing behaviors…Men who have sex with men, November 2003-April 2005. MMWR, 55(SS06),1-16. Figure adapted from Sullivan et al. (2009). Estimating the proportion of HIV transmissions from main sex partners among men who have sex with men in five US cities. AIDS, 23(9),1153-1162.

  29. Target Population: Drug-Involved MSM • Methamphetamine use • Fueling HIV transmission among MSM: • ↑ engagement in sexual risk behavior • ↑ use by HIV-positive • Impairs immune system (Tallóczy et al., 2008) • ↑ viral load (Ellis et al., 2003) • Surveys indicate less use among African American MSM, but… • Estimates of recent meth use among African American MSM range from 10-16% • 49% of African American MSM who used club drugs reported meth use (Halkitis et al., 2005) African American Back Table adapted from Halkitis et al. (2005). Explanations for methamphetamine use among gay and bisexual men in New York City. Substance Use & Misuse, 40(9),1331-1345.

  30. Pilot Test: Measures cont. • Feasibility • Recruitment • Eligibility with respect to population • Eligibility/yield with respect to outreach parameters (e.g., venue, time, active vs. passive) • Retention • Intervention attendance • Follow-up/loss rates • Adverse events • Nature • Frequency • Participant satisfaction Back

  31. Macrosystem Exosystem Microsystem Ontogenic “Meth helps me get my freak on”-KC [FG5] • Sexualizing and sexualstereotypes of Black/AfricanAmerican men • Dealing with objectification • “He likes me because I have a big…”-KC [FG3] • Masculine/“manly” norms vs. being the/a receptive partner • “It’s assumed that you are less of a man when you are the bottom…yes it’s an issue for black gay men.”– KA [FG4] • Methamphetamine: • Psychological disinhibition and cognitive dissociation • Perceived aphrodisiac effects (intensity, prolongation) • Physiological effects: Booty bumping, “instant bottoms”

  32. Macrosystem Exosystem Microsystem Ontogenic “We [Black MSM] are always on the outside looking in”-SM [FG3] • Constant vigilance negotiatingand/or projecting identity • “Where we used to live, we definitely couldn’t hold hands. As soon as we got out of the subway, that was it.”-AK [FG2] • “Those homothugs you see in Chelsea, I can’t stand that.”– MS [FG1] • Marginalization/stereotyping • “What he’s [partner] got is the most important thing: education.”-SM [FG1] • “Those homothugs aint ever going to amount to nothing”-MS [FG1] • Methamphetamine: • Seen as “white” [gay] men’s drug → distancing from “homothugs” • Higher price of meth (vs. cocaine, marijuana) → SES status

  33. Macrosystem Exosystem Microsystem Ontogenic “We [Black male couples] are invisible…it’s as if we don’t exist”-MC [FG5] • Isolation • Couples • “Once we started seeing each other, that was it…it was just the two of us.”-KA [FG3] • “Once we [black gay men] find the perfect guy, we’re not going to let someone take him away.” -MS [FG4] • Community • “We don’t air dirty laundry.” -KA [FG2] • “What goes on in the house stays in the house.” -SM [FG2] • Methamphetamine: • PNP/sex venues as means to connect to/socialize with others • METH can be “blamed” rather than sex and/or relationship issues Back

  34. Additional Analyses:Intervention “Dose” Non Completers Completers Measure at Follow - Up p - value a ( n =11) ( n =54) <x> = 2.37 <x> = 1.41 # of Partners .93 SE = 0.61 SE = 0.15 <x> = 5.27 <x> = 1.57 # Unprotected AI .03 SE = 4.00 SE = .41 <x> = .31 <x> = .79 % Protected AI . 01 SE = .16 SE = .04 <x> = .50 <x> = .89 METH Use Freq. .11 SE = .34 SE = .27 <x> = .62 <x> = .49 Illicit Drug Use Freq. .82 SE = .19 SE = .07 <x> = 2.00 <x> = 1.57 # Types of Illicit Drugs Used .54 SE = 0.54 SE = 0.18 a p-values from Completed × Time term in GLMMwith covariance adjustment as before Back

  35. Additional Analyses:Intervention “Dose” Non Completers Completers Measure at Follow - Up p - valuea ( n =11) ( n =54) <x> = 2.37 <x> = 1.41 # of Partners . 14 SE = 0.61 SE = 0.15 <x> = 5.27 <x> = 1.57 # Unprotected AI . 34 SE = 4.00 SE = .41 <x> = .31 <x> = .79 % Protected AI . 01 SE = .16 SE = .04 <x> = .50 <x> = .89 METH Use Freq. .69 SE = .34 SE = .27 <x> = .62 <x> = .49 Illicit Drug Use Freq. . 49 SE = .19 SE = .07 <x> = 2.00 <x> = 1.57 # Types of Illicit Drugs Used .50 SE = 0.54 SE = 0.18 a p-values from Mann-Whitney U test Back

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  37. Connect With Pride:Session 0 - Orientation • Welcome and introduction to the study • Getting to know the couple • Expectations and Ground Rules for respect and safety • HIV/STI and METH Awareness • Closing

  38. Connect With Pride:Session 1 – Risk Reduction as Self-Care • Welcome & Check-In/Review • Self Care: Introduction • Self-Care: Sexual Health & HIV/STIs • HIV/STI Education • Risk level identification • Condom use skills • Goal Setting • Closing

  39. Connect With Pride:Session 2 – METH & HIV • Welcome & Check-In/Review • METH Knowledge Assessment • The AURA of METH Use • METH Harm Reduction • METH and the Couple • Goal Setting and Homework • Closing

  40. Connect With Pride:Session 3 – Couple Communication • Welcome & Check-In/Review • Communicated Messages About BGM • Communication Styles and Techniques • Strengthening Couple’s Communication Skills • Goal Setting and Homework • Closing

  41. Connect With Pride:Session 4 – Couple Sex Negotiation • Welcome & Check-In/Review • Relationship Myths • Unwritten Rules: Power, & Decision-Making in the Relationship • Couple’s Sex History and Lives • Becoming Safer Sex Gourmets • Goal Setting and Homework • Closing

  42. Connect With Pride:Session 5 – METH, Drugs, & Alcohol • Welcome & Check-In/Review • Perceptions about drug use • Power and Decision-Making in Relationships: A Focus on Drug Involvement • Triggers for Drug Use and Unsafe Sex • Problem Solving Around Triggers • Goal Setting and Homework • Closing

  43. Connect With Pride:Session 6 – Connecting With Pride • Welcome & Check-In/Review • Social Support • Strengthening Positive Support • Relapse Prevention • Rewards for Healthy Behaviors • Commitment to Future Healthy Goals • Closing Ceremony

  44. *

  45. Pilot Test: Analyses • Hypothesis Testing: Participants will engage is less sexual risk behavior following receipt of the couples-based intervention • Need to consider non-independence of measures • Level 2: Individual(s) who provide repeated measures • Level 3: Couple(s) consisting of pairs of individuals (reporting on behaviors with each other) • Generalized Linear Mixed Models (GLMM) • Level 2 and Level 3 nesting treated as random effects • Time treated as a fixed effect (0 = baseline, 1 = follow-up) • Inference based upon the coefficient and standard error for the time term (and associated p-value) • Also tested hypotheses for drug use (secondary outcomes) in an analogous manner    

  46. Pilot Test: Analyses • Hypothesis Testing: Participants will engage is less sexual risk behavior following receipt of the couples-based intervention • Need to consider non-independence of measures • Level 2: Individual(s) who provide repeated measures • Level 3: Couple(s) consisting of pairs of individuals (reporting on behaviors with each other) • Generalized Linear Mixed Models (GLMM) • Level 2 and Level 3 nesting treated as random effects • Time treated as a fixed effect (0 = baseline, 1 = follow-up) • Inference based upon the coefficient and standard error for the time term (and associated p-value) • Also tested hypotheses for drug use (secondary outcomes) in an analogous manner Participant Time Time 0 1 €   X X 0 1 ‚   X X 0 1

  47. Pilot Test: Baseline Characteristics(N = 68 individuals)

  48. Hypothesis Testing: Sexual Risk †p < .10; *p < .05; **p < .01; ***p < .001

  49. Hypothesis Testing: Drug Use †p < .10; *p < .05; **p < .01; ***p < .001

  50. Additional Analyses:Intervention “Dose” a p-values from Completed × Time term in GLMMwith covariance adjustment as before Back

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