Age: ranged from 29 to 48 years old All but 3 were Black (1 Caucasian, 2 Biracial-Black/Latino) COUPLE LEVEL (N = 8 couples) Both partners used METH in past 2 mos.: 2 (25%) Focus Group with Service Providers (n=8) Review findings from focus groups with target population Inform feasibility and safety/ethical issues Recruitment Feedback and suggestions Program Review Panel Information/materials are understandable Accuracy with respect to HIV (e.g., risk/prevention [behaviors], effectiveness) and program content (e.g., titles are accurate) Materials and activities are appropriate Community Advisory Board Review and provide feedback on progress Assistance in overcoming challenges Dissemination opportunities

Cultural Humility (Tervalon & Murray-Garcia, 1998, Journal of Health Care for the Poor and Underserved): does include power imbalance but focused on power imbalance between service provider and client (though does lead to consonant “patient-oriented interviewing and care”)

Note: This matrix is really only for illustrative purposes…in particular, session 2 rows don’t match the actual session 2 (it’s really session 3’s content, which I used because it shows more “couple” content)

Assessed for Eligibility: n=14 individuals Excluded: n=62 individuals Not interested/Did not respond after initial outreach contact: n=22 individuals Ineligible: n=34 individuals Enrolled: n=68 individuals / 34 couples Discontinued Ix: n=12 individuals/6 couples Partner entered residential drug Tx: n = 2 couples Partner incarcerated: n = 1 couple Couple broke up during Ix: n=2 couples Non-compliance: n=1 couple Followup: n = 65 individuals Lost 2º incarceration: n=2 individuals Lost contact: n=1 individual

Non-independence due to couples: Can’t just do “typical” pre-/post- tests such as dependent t-test, Wilcoxon Rank test (for non-normal), or McNemar (for categorical)

Age: ranged from 21 to 59 years old Sexual orientation: Gay: 57 (84%) Bisexual: 9 (13%) Straight: 2 (3%) Employed: Unemployed: 60 (88%) Employed Part-Time: 6 (9%) Employed Full-Time: 2 (3%) COUPLE LEVEL (N = 34 couples) Both partners used METH: 19 (56%) Both partners have extradyadic partners: 31 (91%) Serodiscordant couples: 4 (11%) [rest are HIV+/HIV+]

>1 [sexual] partner BL: 84% (Note: this is lower than % extradyadic because some people reported no sex w/main partner) FU: 31%

Used METH BL: 78% FU: 37% Used Any Illicit Drugs BL: 94% (54% of sample used THC, 32% crack cocaine, 21% powdered cocaine) FU: 78%

References CDC, 2008: Centers for Disease Control and Prevention. HIV/AIDS Surveillance Report, 2006. Vol. 18. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention; 2008

References NYCDOHMH: http://home2.nyc.gov/html/doh/html/ah/ah.shtml#reports NY numbers are 1 in XX of group are infect w/HIV

For black MSM, 1.3 time as likely to have unprotected anal sex w/man vs. casual partner For unprotected sex w/HIV+ partner, ~2.1 for unprotected insertive w/HIV+, ~2.0 for unprotected receptive w/HIV+

References Tallóczy et al. (2008). Methamphetamine Inhibits Antigen Processing, Presentation, and Phagocytosis. PLOS Pathogens, 4(2), e28. Meth Use among white about 50% higher than Black MSM (i.e., in one study, Black was 10%, White was 15%; another study black was 15%, white was 22%); in one study at NC, Black was higher than white (16% vs. 10%) Halkitis (2008 Addictive Behaviors): 11% of meth using MSM (in their club drug study) were Black Are some regional difference with Meth use NHBS study in NY found 7% of black MSM (compared to 17% for whites in NYC

Anal physiology: booty bumping increases receptivity, instant bottom (Frosh et al, 1990 as cited in Halkitis, 2001 J Homosexuality)

Anal physiology: booty bumping increases receptivity, instant bottom (Frosh et al, 1990 as cited in Halkitis, 2001 J Homosexuality)

Anal physiology: booty bumping increases receptivity, instant bottom (Frosh et al, 1990 as cited in Halkitis, 2001 J Homosexuality)

B from METH use is in direction of reduced METH use (i.e., controls for lower METH use frequency among non-completers at baseline)

Note: METH use frequency at baseline significantly lower among non-completers than completers <x> = 1.55 vs. 3.04 respectively, p=.03 w/M-W U test

Age: ranged from 21 to 59 years old Sexual orientation: Gay: 57 (84%) Bisexual: 9 (13%) Straight: 2 (3%) Employed: Unemployed: 60 (88%) Employed Part-Time: 6 (9%) Employed Full-Time: 2 (3%) COUPLE LEVEL (N = 34 couples) Both partners used METH: 19 (56%) Both partners have extradyadic partners: 31 (91%) Serodiscordant couples: 4 (11%) [rest are HIV+/HIV+]

B from METH use is in direction of reduced METH use (i.e., controls for lower METH use frequency among non-completers at baseline)

Note: METH use frequency at baseline significantly lower among non-completers than completers <x> = 1.55 vs. 3.04 respectively, p=.03 w/M-W U test

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

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 Towards Couple-Based Sexual Risk Reduction for Men who Have Sex With Men (MSM)… 1

2 Targeting an At-Risk Population: “Methamphetamine-Involved, Black MSM couples” MSM METH-Involved African American Established Relationship

3 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

4 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

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 5 Formative Work: Adaptation Qualitative Data/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.

6 Vicious Cycles Methamphetamine use Physiological & psychological sequelae Arguments Meth use ↕ HIV risk Issues affecting the relationship

7 Interactional and structural factors that are part of the immediate intimate relationship context in which sexual activity and risk and protective behaviors occur 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 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 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 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 METH, HIV, & Black MSM: Analyzing/Incorporating Experiences and Worldviews 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 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 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

Theoretical Framework 8 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

9 Revising the Existing Ix: The Starting Point Social Support Self-Efficacy Social & Self-Regulatory Skills Outcome Expectancies • Couple-based approach • Overcoming barriers to participating • Commitment contract • Pros/cons of participating • Purpose Information Revise

10 Session SCT Construct 10

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 Pilot Test of Connect With Pride 11 Recruitment & Screening Pre-Test (“Baseline”) Intervention Delivery Post-Test (“Follow-Up”)

Pilot Test: Measures 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 12 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 Feasibility

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 13 € ‚ ↕

Pilot Test: Baseline Characteristics (N = 68 individuals) 14 Age (yrs.) < x > = 41.5 ( SD = 8.7) Employed n = 8 (12%) Has ≥HS Diploma/ GED n = 57 (84%) Income over past 12 mos. ( × $1000) < x > = 12.6 ( SD = 9.9) Race African American/Black Latino Mixed n = 62 (91%) n = 5 (7%) n = 1 (2%) HIV - Positive n = 64 (94%) Variables Distribution

Pilot Test Results: Sexual Risk Measures 15 Notes: Graphs display means, with associated standard errors indicated by the rising stem BL = Baseline (N = 68) FU = Follow-Up (N = 65) # Sexual Partners # Unprotected AI % Protected AI

Hypothesis Testing: Sexual Risk 16 †p < .10; *p < .05; **p < .01; ***p < .001 # Sexual Partners Time - 2.84 *** ( 0.70) Age (yrs.) - 0.08 † (0.05) Employed - 0.53 (1.19) Has HS diploma/ GED - 1.32 (1.04) Annual income ( × $1000) 0.04 (0.04) Is Black/African American 0.76 (1.67) Is HIV - positive - 0.004 (1.64) Used METH 2 mos. prior to enrollment 1.25 (0. 86)

Pilot Test Results: Drug Use Measures 17 Notes: Graphs display means, with associated standard errors indicated by the rising stem BL = Baseline (N = 68) FU = Follow-Up (N = 65) METH Use Freq. Illicit Drug Use Freq. # Types of Illicit Drugs Used 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

Hypothesis Testing: Drug Use 18 †p < .10; *p < .05; **p < .01; ***p < .001 METH Use Freq. Time - 1.85*** (0.28) Age (yrs.) - 0.04 † (0.02) Employed - 0.25 (0.68) Has HS diploma/ GED 0.26 (0.57) Annual income ( × $1000) 0.01 (0.02) Is Black/African American 1.17 (0.86) Is HIV - positive 1.40 (0.89)

19 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

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 20 “Dose” Analyses

21 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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Male-to-male sexual contact represents the largest 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 23 MSM are actually losing ground in the fight to prevent HIV transmission! Target Population: MSM 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. Back New York City is an HIV epicenter 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).

Need another reason for renewed or new HIV prevention efforts for MSM? 24 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

25 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. Target Population: African Americans are disproportionately affected 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 with HIV/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 MSM African American Back

26 Target Population: MSM in more established relationships may be at elevated risk for HIV transmission ~1.5 times as likely to have unprotected anal 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 is a main partner vs. casual partner (Sanchez et al., 2006) Majority of HIV transmissions among MSM are from main sex partners MSM Established Relationship 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. Back 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.

27 Target Population: 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) 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. MSM Drug-Involved African American Back

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 28 Back

29 “Meth helps me get my freak on” -KC [FG5] Sexualizing and sexual stereotypes of Black/African American 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”

30 “We [Black MSM] are always on the outside looking in” -SM [FG3] Constant vigilance negotiating and/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

31 “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

Additional Analyses: Intervention “Dose” 32 Back a p-values from Completed × Time term in GLMM with covariance adjustment as before Measure at Follow - Up Non Completers ( n =11) Completers ( n =54) p - value a # of Partners <x> = 2.37 SE = 0.61 <x> = 1.41 SE = 0.15 .93 # Unprotected AI <x> = 5.27 SE = 4.00 <x> = 1.57 SE = .41 .03 % Protected AI <x> = .31 SE = .16 <x> = .79 SE = .04 . 01

Additional Analyses: Intervention “Dose” 33 Back a p-values from Mann-Whitney U test Measure at Follow - Up Non Completers ( n =11) Completers ( n =54) p - valuea # of Partners <x> = 2.37 SE = 0.61 <x> = 1.41 SE = 0.15 . 14 # Unprotected AI <x> = 5.27 SE = 4.00 <x> = 1.57 SE = .41 . 34 % Protected AI <x> = .31 SE = .16 <x> = .79 SE = .04 . 01

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35 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

36 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

37 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

38 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

39 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

40 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

41 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

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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 43    

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 44     Participant Time 0 Time 1 € X 0 X 1 ‚ X 0 X 1

Pilot Test: Baseline Characteristics (N = 68 individuals) 45

Hypothesis Testing: Sexual Risk 46 †p < .10; *p < .05; **p < .01; ***p < .001

Hypothesis Testing: Drug Use 47 †p < .10; *p < .05; **p < .01; ***p < .001

Additional Analyses: Intervention “Dose” 48 Back a p-values from Completed × Time term in GLMM with covariance adjustment as before

Additional Analyses: Intervention “Dose” 49 Back a p-values from Mann-Whitney U test