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Domestic HIV Prevention Research Agenda: Women At Risk June 7, 2007 DWPG-Women at Risk Members Andrew Forsyth Ann O'Leary Danielle Haley David Metzger Dawn Smith Eunice Ramirez-Dilone Jessica Justman Katherine Davenny Nicolette Borek Peter Kilmarx Richard Jenkins Sally Hodder Scott Rose Sten H. Vermund Tim Mastro Vanessa Johnson Waheedah Shabbaz-El Ada Adimora Cathie Fogel David Burns David Purcell Dianne Rausch Gina Wingood Jim Hughes Kendall Bryant Nirupama Sista Quarraisha Abdool Karim Richard Wolitski Sandra Lerhman Sheryl Zwerski Sue Gibson Victoria Cargill Wafaa El-Sadr Outline Epidemiology of HIV in US women – Defining populations at risk HIV incidence in US women Gap analysis – Review biomedical and behavioral interventions in women – Gap delineation Proposed concepts New Jersey HIV Prevalence (per 100,000 women) State of New Jersey Newark EMA Essex County Newark Black women in Newark 263 618 927 1417 2673 Persons living with AIDS in Philadelphia, June 2006 North Carolina HIV/STI Rates, 2006 HIV Incidence in US women makes RCT feasible 3.14/100 PY Baltimore IDU 2.32/100 PY Philadelphia, Black Women 4.1/100PY Atlanta, GA VCT Clinic (81% AfricanAmerican and 40% female recruited in 02-04 using BED EIA) 1.33/100 PY Control Arm, Rakai Circumcision Trial Strathdee SA et al Arch Int Med 161:1281, 2001; Metzger D, Unpublished Data; Gray et al, Lancet Feb 2007; Priddy, F et al., JAIDS, 2007 Risk Factors for HIV incidence among STI clinic attendees Dates: 1993-2002 Location: Baltimore Size: 10,535 (13,693 py) Incidence: 0 .91 / 100 PY (overall) 4.86 / 100 PY (HIV+ partner) 3.06 / 100 PY (IDU) 2.40 / 100 PY (genital ulcers) Metha SD et al, JAIDS, 2006 Young Blacks with Low Risk Behavior Have More HIV Than Young Whites Behavior Pattern Adjusted* Odds Ratio Blacks to Whites Low Risk Behavior 24.9 *Adjusted for gender, marital status, school dropout, poverty Hallfors et al. Am J Pub Health 97:125, 2007 Target Population African - American Women • Location, location, location • Partner characteristics • Individual characteristics Black HIV Prevalent Home Neighborhood Geography High risk male partner HIV + male partner Partner Characteristics Recent STI: HSV2 GC Drug use: IDU Cocaine Women’s Characteristics HIV and Incarceration: Parallel Epidemics 1 in 3 black men will be incarcerated (lifetime) compared with 1 in 17 white men Black women are 7 times more likely to be incarcerated during their lifetime than White women In NC state prison system, estimated HIV prevalence rate is 1.9% for men and 3.1% for women Approximately 10-20% of 14,000 inmates in NYC jails are HIV+ In 1999, 18% of new female entrants in NYC jails were HIV+ compared to 7.6% of men Freundenberg, 2002; Hammett et al, 2002; BJS, 2006; NYC Department of Health, 1999 and 2006 AIDS in Prison Interventions in Women Biomedical Behavioral Biomedical Interventions in Women Exclusive of Vaccine & Microbicide Studies PREP: West Africa Study complete but lacking power to demonstrate efficacy Ongoing studies in women (non-US): – HSV suppression – Diaphragm – PREP STI treatment as an intervention to lower HIV demonstrated conflicting data (non US) STI Treatment to Prevent HIV “STI treatment may decrease HIV incidence in emerging HIV epidemic (low & slowly rising prevalence)” Trial Intervention Rakai 3 rounds Comm. Rx OR (95%CI) 0.97 (.81-1.16) Mwanza Syndromic Rx 0.58 (.42-.70) Masaka 1.00 (.63-1.58) Behavioral + STI Rx Grosskurth H, 1995; Kamali A, 2003, Wawer, 1999; Sangani, 2004 Evidence-Based Behavioral Interventions Targeting Women (Lyles, et al, 2007) RCT Trial Population Endpoints SiHLE (DiClemente, 2004) AA Girls 14-18 Decreased STIs, Increased condom use Choices (Baker, 2003) Low income heterosexual women Decreased STIs Project FIO (Ehrhardt, 2002) Heterosexual women in family planning clinics Decreased unprotected VI/AI, Decreased VI/AI Project ConnectAA and Latino couple or woman heterosexual alone (El-Bassel, 2003) couples Increased condom use, Decreased unprotected VI RCT Trial Population Endpoints Project S.A.F.E (Shain, Mexican American and Decreased STIs, 2004) AA women dx’d with Decreased unprotected STIs in public clinics sex, decreased N of sexual partners Female and Culturally Specific Negotiation (Sterk, 2003) Inner-city, HIV-, sexually active, out-oftreatment crack or IDU using women decreased sex with paying customers, decreased trading of sex for money, decreased IDU Women’s Co-op (Wechsberg, 2004) Inner-city(south), HIV-, Decreased unprotected sexually active, out-of- sex treatment crack using AA women WiLLOW (Wingood, 2004) Sexually active HIV+ female clinic patients Increased condom use FOK+ImPACT (Wu, Stanton, 2003) Low income AA youth Decreased STIs, decreased unprotected VI Existing Gaps in Domestic HIV Prevention in Women Few biomedical intervention trials have been completed – Conflicting data on STI treatment – No PEP studies – No PREP efficacy Small number of evidence-based behavioral interventions available for population – No studies with HIV seroconversion as an endpoint – Durability of intervention is unknown as follow-up limited to < 1 year – Few studies specifically address social networks Few studies target intervention to women’s partners Existing Gaps in Domestic HIV Prevention in Women (cont.) Internet as a social networking tool on HIV transmission in women Scant data on alcohol and non-IDU interventions Effectiveness studies lacking Cost Effectiveness of prevention interventions Unifying Themes Interventions to focus on identified populations with high HIV prevalence/incidence (by U.S. standards) – Decrease HIV acquisition in at-risk women – Decrease HIV transmission by their male partners Consideration of biomedical & behavioral interventions (stand alone or in combination) HIV incidence as the primary endpoint Duration of follow-up > 1 year Concepts nPEP in HIV- women: – Vanguard cohort – Definitive study STI Treatment Behavioral intervention in HIV+ men Behavioral intervention in HIV- women being released from prison and jails Combined Intervention nPEP Concept: Impact of Access to Non-occupational Post-Exposure Prophylaxis Rationale: – nPEP guidelines exist and nPEP is in use yet no RCT studies of nPEP have been done – Little to no data on use of nPEP in women – Combinations of interventions need to be assesses Objectives – To assess the impact of access to nPEP using a combined nPEP plus behavioral/informational approach on HIV seroincidence among HIV-negative African-American women with defined high risk factors nPEP Concept: Design Phase III randomized control trial with 2 arms, and 2 years of follow-up: – Arm 1: Control group: group counseling sessions to include brief risk reduction/safe sex content plus other content such as money management, nutrition, exercise. Participants will receive condoms. – Arm 2: nPEP Plus: group counseling sessions to include brief risk reduction/safe sex content, plus discussion of nPEP, and a supply of condoms and nPEP (such as TDF/ZDV/3TC) to be commenced immediately after unprotected vaginal or anal intercourse. Four weeks of ART would be recommended after an exposure. – Background seroincidence rate: May be estimated by running BED-type detuned assays on all the HIV-positive women screened for the study, plus NAAT for HIV RNA on pooled samples from all HIV-negative women screened and otherwise eligible. nPEP Concept Endpoints – Primary: HIV seroincidence (monthly vs quarterly testing) – Secondary: combined HIV + STI incidence, condom use frequency, nPEP use frequency and acceptability, # partners with risk characteristics Inclusion Criteria HIV-negative African American women with at least one defining risk factors: – sexual intercourse with HIV-infected male partner(s) at least once once in 30 days prior to screening [known status vs unknown status] – number of lifetime partners, – history of exchanging sex for drugs or money, – history of > 2 STIs, – substance use history – recent or anticipated release from jail or prison – other sexual network characteristics (to be further defined); nPEP Concept: Discussion Points – control group: low intensity intervention vs. higher intensity behavioral intervention? Advantage of low intensity: ability to assess impact of a more feasible intervention. Advantage of higher intensity: ability to assess impact of nPEPControl group: – Inclusion criteria: sexual intercourse with HIV-infected male partner(s) at least once once in 30 days prior to screening [known status vs unknown status] – Will many PEP users repeat PEP frequently, and therefore approximate PREP? – Monthly, every other month or quarterly study visits? nPEP: Vanguard study Qualitative study of nPEP among women who would be potential participants – Focus groups – Individual interviews Acceptability, HIV risk perceptions, awareness of nPEP, awareness of other prevention methods Intensive STI Treatment Rationale: – Conflicting data regarding efficacy of STI treatment to decrease HIV acquisition – At risk women of color reside in communities with high STI rates Design: Phase III RCT with a 24 month follow-up period. Study Population: HIV-negative African American women with at least one defining risk factors: – sexual intercourse with HIV-infected male partner(s) at least once once in 30 days prior to screening – history of exchanging sex for drugs or money, – history of > 2 STIs, – substance use history Intensive STI Treatment Intervention: Arm 1: (Control group) safe sex and condom distribution Arm 2: Intensive (3X yearly) assessment/treatment for gonorrhea, Chlamydia, and syphilis Endpoints: – Primary: HIV seroincidence (yearly testing) – Secondary: Episodes of unprotected sex # partners Intensive STI Treatment Discussion Points Exclusion of HSV-2 seropositive persons Partner treatment vouchers Frequency of follow-up Sample size requirements Behavioral Intervention Targeting AfricanAmericans HIV+ men & their female partners Rationale: Few HIV prevention studies target African-American males. Innovative study designed to reduce HIV in female partners. Design: A phase III RCT with an 18-month follow-up period. Sample: HIV+ African-American males, 18 and older recruited from various venues (HIV clinics, STI clinics, prisons) and who have had vaginal/anal sex with female sexual partner. And female sexual network partners, 18 years+ who provide consent. Assess: In males we will consider: (1) ACASI, (2) HIV testing, (3) STI testing, and (4) HIV typing and (5) viral loads. Assess: In females we will consider: (1) ACASI, (2) HIV testing and HIV typing. HIV+ Males and Female Partners (cont.) Intervention (male): Arm 1 (Control): Males receive 4 group sessions on fitness and 5 individual sessions on fitness. Arm 2: Males receive 4 adapted group sessions of two EBIs, Healthy Relationships and WiLLOW and, 5 individual sessions adapted from RESPECT. Female partners receive HIV pretest/postest counseling. 1o Outcome: To reduce the HIV incidence in the treatment condition compared to a control condition over an 18-month follow-up period, as indicated by acquisition of HIV in HIV- female sexual network partners. (Should explore reinfection in males and HIV+ female network partners?) HIV+ Males and Female Partners Discussion points Sample size requirements Likelihood of male participant referring female sexual network partners Identification of female sexual network partners Retention over extended follow-up Behavioral intervention for HIV- women exiting jails and prisons Rationale: Nexus of HIV, incarceration, and drug use in U.S. well documented. Female inmates especially vulnerable to HIV infection, not only biologically, but through social forces such as poverty and social networks characterized by drug use and domestic violence. Design: Phase III RCT with a 24 month follow-up period. Sample: HIV negative female inmates, between one month and one year of release, who report a history of unprotected heterosexual sex, drug use, are > 18 years of age Intervention: Arm 1 (Control): NIDA standard intervention Arm 2: Adapted female and culturally enhanced motivation intervention + booster (Sterk et al, 2003). 4 sessions: 1 pre-release, 3 post-release +2 post-release boosters HIV Reduction for HIV- Female Inmates (cont.) Assessments (pre- and post-release) Pre-release. (1) ACASI survey (2) Chart reviews to assess medical history (STIs upon intake, mental health, general health). Post release assessments (2 weeks, 1-month, 2-, 46-, 9-,12-,15-, 18-,21, 24 months post-release) (1) ACASI (per above) (2) STIs and drug screening (3) HIV testing (standard and PCR). HIV- Female Inmates Endpoints Primary Outcome: To reduce the HIV incidence in the treatment condition compared to the control condition over a 24-month followup period. Secondary Outcomes: To evaluate STI incidence as well as drug use and sexual risk behaviors/mediators in treatment condition compared to the control condition over a 24month follow-up period. HIV- Female Inmates Discussion points Sample size requirements Retention over 2 year period Unique needs of incarcerated female populations Established relationships with prison, but little experience with jails Combining “Women at risk” & “Partners of high risk HIV+ men” Two-level factorial design Level 1: Male intervention – Community randomized trial (CRT) of a behavioral intervention among HIV+ heterosexual men to reduce HIV transmission Level 2: Female intervention – Within each community, randomize a cohort of high risk, HIV-negative women to a female risk reduction intervention Primary outcome is HIV infection in the women enrolled in the cohorts Discussion Points Design allows addresses multiple questions – What is the direct effect of the female intervention (FI)? – What is the community level effect of the male intervention (MI)? – What is the incremental effect of the MI above and beyond the risk reduction achieved by the FI? – Are the 2 interventions supplemental, independent, or synergistic Need to ensure males reached in the MI represent the pool of potential partners of females enrolled in the cohorts. Sample size requirements Community Men Intervention Community Women Intervention Control Control MI WI M0 WI MI W0 M0 W0 Conclusions Incidence data support feasibility of a prevention intervention with HIV incidence as endpoint New insights into women at risk Research gaps defined in behavioral and biomedical interventions Innovative approaches identified Opportunity to stem HIV transmission in the US Back Up Characteristics of heterosexually acquired infections in the US: 1999 - 2004 Dates: 1999 - 2004 Location: 29 US states with name-based reporting Size: 52,569 Correlates: – 69% women – 73% Black – significant increases among Hispanics Espinoza L et al, AJPH 2007