1. Seropositive Urban Men’s Intervention Trial (SUMIT) Richard Wolitski, Cynthia Gomez, Jeffrey Parsons, and the SUMIT Study Group Prevention Interventions with Persons Living with HIV/AIDS: NIH/CDC/HRSA Update Atlanta, GA July 26-27, 2003

2. SUMIT Study Group David Bimbi (Graduate Center, CUNY) Colleen Hoff (UCSF) Perry Halkitis (NYU) David Purcell (CDC) Ann O’Leary (CDC) Cynthia Lyles (CDC) Bill Woods (UCSF)

3. Background Randomized controlled trial HIV-seropositive gay and bisexual men New York City and San Francisco January 2000 to March 2002 Study arms –Comparison: 1-session community forum –Treatment: 6-session peer-led group intervention

4. Intervention Goals and Outcomes Primary Outcomes –Decrease frequency of UIAI, URAI, and UIOI with negative/unknown status partners –Increase percentage of condom-protected acts for UIAI with negative/unknown status partners Secondary Outcome –Increase proportion of men who disclosed their HIV status to partners prior to sex

5. Intervention Conditions Community Forum—1½ hours –Expert panel Update on issues affecting HIV transmission Relative risk of specific sexual practices for self and partners Harm reduction philosophy Promoted personal decision making –Question and answer period

6. Enhanced 6-Session Intervention—3 hours –Weekly events focused on a specific issue –Content and structure informed by: Seropositive Urban Men’s Study (SUMS) Literature review Health behavior theory Advisory group and HIV+ members of research team –Large and small group activities Facilitated by HIV-positive peers Unstructured time for social interaction

7. Intervention Content Building connections with other HIV+ MSM Transmission risk of specific behaviors, STDs, re- infection Personal responsibility Assumptions & disclosure of serostatus, communication skills Substance use and effects on sexual behavior & immune system Coping with HIV & impact of mental health on sexual behaviors & health care

8. Methods Convenience sample –Active and passive recruitment –Oversampled men of color Screened for eligibility via telephone 18 years of age or older Sex with HIV-negative/unknown status male partner in past year English speaking Available to attend first intervention session HIV status documented at baseline assessment

9. Methods (cont.) A-CASI assessments at baseline and 3 months and 6 months following intervention –Sex behavior—prior 90 days Partner type (main vs. non-main) Partner serostatus (disclosed positive, disclosed negative, unknown) Optional STD testing at baseline and 6 months Chlamydia Gonorrhea HSV-1 and HSV-2 Syphilis

10. Methods (cont.) 1,168 participants completed baseline 811 (69%) were randomized and attended the first intervention session Excellent retention –88% at 3 months (n = 714) –90% at 6 months (n = 727)

11. Process Data Good attendance at intervention sessions –75% attended 4 or more sessions Both interventions were rated favorably on satisfaction measures –6-session intervention rated more favorably

12. Demographics (n =811) City –New York52% –San Francisco48% Race/Ethnicity –Black/African American23% –Hispanic/Latino17% –White/Caucasian51% –Other 9%

13. Sexual orientation –Gay88% –Bisexual12% –Heterosexual/none of above/not sure<1% Age –Mean = 42 yrs ( Range = 20- 89, SD = 8.0) Time since HIV diagnosis –Mean = 8.7 yrs (Range = 1 wk – 17.3 yrs, SD = 5.0) Diagnosed with AIDS50 % Taking HIV medication80% Undetectable viral load40%

14. Summary of Preliminary Outcomes Combined analyses (n = 811) –Differential reduction in risk for 6-session intervention at 3 months for: UIAI with negative/unknown status partners URAI with negative/unknown status partners UIOI with negative/unknown status partners –In general, intervention effects were not maintained at 6 months –The intervention effects differed by city Positive/neutral effects at six months in one city Negative effects in the other

15. On-Going Analyses Working to understanding city differences –Participant characteristics and risk behavior –Study procedures/implementation –9/11 terrorist attacks Effects of intervention content Effects for main versus non-main partners Disclosure of HIV status

16. Issues to Consider How should trials that control for demand be compared with those that do not? How long should we expect intervention effects to be maintained? If specific content is linked to outcomes, what should be disseminated? Should an intervention be disseminated if it “works” in only one city?