Susan Tross

Effects of a behavioral intervention to reduce risk of transmission among people living with HIV: The Healthy Living Project randomized controlled study

Context:The US Centers for Disease Control and Prevention (CDC) strongly recommend comprehensive risk counceling and services for people living with HIV (PLH); yet, there are no evidence-based counseling protocols. Objective:To examine the effect of a 15-session, individually delivered, cognitive behavioral intervention on a diverse sample of PLH at risk of transmitting to others. Design:This was a multisite, 2-group, randomized, controlled trial. Participants:Nine hundred thirty-six HIV-infected participants considered to be at risk of transmitting HIV of 3818 persons screened were randomized into the trial. Participants were recruited in Los Angeles, Milwaukee, New York, and San Francisco. Intervention:Fifteen 90-minute individually delivered intervention sessions were divided into 3 modules: stress, coping, and adjustment; safer behaviors; and health behaviors. The control group received no intervention until the trial was completed. Both groups completed follow-up assessments at 5, 10, 15, 20, and 25 months after randomization. Main Outcome Measure:Transmission risk, as measured by the number of unprotected sexual risk acts with persons of HIV-negative or unknown status, was the main outcome measure. Results:Overall, a significance difference in mean transmission risk acts was shown between the intervention and control arms over 5 to 25 months (χ2 = 16.0, degrees of freedom = 5; P = 0.007). The greatest reduction occurred at the 20-month follow-up, with a 36% reduction in the intervention group compared with the control group. Conclusion:Cognitive behavioral intervention programs can effectively reduce the potential of HIV transmission to others among PLH who report significant transmission risk behavior.

Effectiveness of HIV/STD Sexual Risk Reduction Groups for Women in Substance Abuse Treatment Programs : Results of NIDA Clinical Trials Network Trial

Context:Because drug-involved women are among the fastest growing groups with AIDS, sexual risk reduction intervention for them is a public health imperative. Objective:To test effectiveness of HIV/STD safer sex skills building (SSB) groups for women in community drug treatment. Design:Randomized trial of SSB versus standard HIV/STD Education (HE); assessments at baseline, 3 and 6 months. Participants:Women recruited from 12 methadone or psychosocial treatment programs in Clinical Trials Network of National Institute on Drug Abuse. Five hundred fifteen women with ≥1 unprotected vaginal or anal sex occasion (USO) with a male partner in the past 6 months were randomized. Interventions:In SSB, five 90-minute groups used problem solving and skills rehearsal to increase HIV/STD risk awareness, condom use, and partner negotiation skills. In HE, one 60-minute group covered HIV/STD disease, testing, treatment, and prevention information. Main Outcome:Number of USOs at follow-up. Results:A significant difference in mean USOs was obtained between SSB and HE over time (F = 67.2, P < 0.0001). At 3 months, significant decrements were observed in both conditions. At 6 months, SSB maintained the decrease and HE returned to baseline (P < 0.0377). Women in SSB had 29% fewer USOs than those in HE. Conclusions:Skills building interventions can produce ongoing sexual risk reduction in women in community drug treatment.

Motivational and skills training HIV/sexually transmitted infection sexual risk reduction groups for men

The effectiveness of a motivational and skills training HIV/AIDS group intervention designed for men in substance abuse treatment was evaluated. Men in methadone maintenance (n = 288) or outpatient psychosocial treatment (n = 302) completed assessments at baseline, 2 weeks, 3 months, and 6 months postintervention. Participants were randomly assigned to attend either Real Men Are Safe (REMAS; five sessions containing information, motivational exercises, and skills training) or HIV education (HIV-Ed; one session containing HIV prevention information). REMAS participants engaged in significantly fewer unprotected vaginal and anal sexual intercourse occasions (USO) during the 90 days prior to the 3- and 6-month follow-ups than HIV-Ed participants. Completing REMAS resulted in an even stronger effect: Completers reduced their number of USO by 21% from baseline to 6-month follow-up. In contrast, HIV-Ed completers increased the number of USO by 2%. A motivational and skills training HIV prevention intervention designed for men was associated with greater sexual risk reduction over standard HIV-Ed. Substance abuse treatment programs can therefore help reduce sexual risk among their clientele by providing a more intensive intervention than what is traditionally provided.

Implementing rapid HIV testing with or without risk-reduction counseling in drug treatment centers: Results of a randomized trial

OBJECTIVES We examined the effectiveness of risk reduction counseling and the role of on-site HIV testing in drug treatment. METHODS Between January and May 2009, we randomized 1281 HIV-negative (or status unknown) adults who reported no past-year HIV testing to (1) referral for off-site HIV testing, (2) HIV risk-reduction counseling with on-site rapid HIV testing, or (3) verbal information about testing only with on-site rapid HIV testing. RESULTS We defined 2 primary self-reported outcomes a priori: receipt of HIV test results and unprotected anal or vaginal intercourse episodes at 6-month follow-up. The combined on-site rapid testing participants received more HIV test results than off-site testing referral participants (P<.001; Mantel-Haenszel risk ratio=4.52; 97.5% confidence interval [CI]=3.57, 5.72). At 6 months, there were no significant differences in unprotected intercourse episodes between the combined on-site testing arms and the referral arm (P=.39; incidence rate ratio [IRR]=1.04; 97.5% CI=0.95, 1.14) or the 2 on-site testing arms (P=.81; IRR=1.03; 97.5% CI=0.84, 1.26). CONCLUSIONS This study demonstrated on-site rapid HIV testings value in drug treatment centers and found no additional benefit from HIV sexual risk-reduction counseling.

Effect of risk-reduction counseling with rapid HIV testing on risk of acquiring sexually transmitted infections: The AWARE randomized clinical trial

IMPORTANCE To increase human immunodeficiency virus (HIV) testing rates, many institutions and jurisdictions have revised policies to make the testing process rapid, simple, and routine. A major issue for testing scale-up efforts is the effectiveness of HIV risk-reduction counseling, which has historically been an integral part of the HIV testing process. OBJECTIVE To assess the effect of brief patient-centered risk-reduction counseling at the time of a rapid HIV test on the subsequent acquisition of sexually transmitted infections (STIs). DESIGN, SETTING, AND PARTICIPANTS From April to December 2010, Project AWARE randomized 5012 patients from 9 sexually transmitted disease (STD) clinics in the United States to receive either brief patient-centered HIV risk-reduction counseling with a rapid HIV test or the rapid HIV test with information only. Participants were assessed for multiple STIs at both baseline and 6-month follow-up. INTERVENTIONS Participants randomized to counseling received individual patient-centered risk-reduction counseling based on an evidence-based model. The core elements included a focus on the patients specific HIV/STI risk behavior and negotiation of realistic and achievable risk-reduction steps. All participants received a rapid HIV test. MAIN OUTCOMES AND MEASURES The prespecified outcome was a composite end point of cumulative incidence of any of the measured STIs over 6 months. All participants were tested for Neisseria gonorrhoeae, Chlamydia trachomatis, Treponema pallidum (syphilis), herpes simplex virus 2, and HIV. Women were also tested for Trichomonas vaginalis. RESULTS There was no significant difference in 6-month composite STI incidence by study group (adjusted risk ratio, 1.12; 95% CI, 0.94-1.33). There were 250 of 2039 incident cases (12.3%) in the counseling group and 226 of 2032 (11.1%) in the information-only group. CONCLUSION AND RELEVANCE Risk-reduction counseling in conjunction with a rapid HIV test did not significantly affect STI acquisition among STD clinic patients, suggesting no added benefit from brief patient-centered risk-reduction counseling. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01154296.

PrEP in substance abuse treatment: a qualitative study of treatment provider perspectives

ObjectivesTo examine substance abuse treatment providers’ views on engaging clients in Pre-exposure Prophylaxis (PrEP) care and research trials.MethodsThirty-six medical and counseling service providers in six New York City outpatient substance abuse treatment programs participated in semi-structured qualitative interviews. Thematic content analysis was conducted by three coders, independently.ResultsProviders’ perspectives toward PrEP were characterized by six salient themes: 1) Limited PrEP awareness. 2) Ambivalence about PrEP; 3) Perception of multiple challenges to delivery; 4) Uncertainty about clients’ ability to be adherent to medication; 5) Concerns about medication safety/side effects; and 6) Perception of multiple barriers to conducting clinical trials.ConclusionsDespite anticipated challenges, providers supported the introduction of PrEP in outpatient substance abuse treatment. Comprehensive training for providers is needed and should include PrEP eligibility criteria, strategies to support adherence and medication monitoring guidelines. Linkages between substance abuse treatment and primary care and/or enhancement of capacity within clinics to offer PrEP may help facilitate PrEP delivery. When conducting research in outpatient clinics, it is particularly important to protect client confidentiality.

Effect of Patient navigation with or without financial incentives on viral suppression among hospitalized patients with HIV infection and substance use a randomized clinical trial

IMPORTANCE Substance use is a major driver of the HIV epidemic and is associated with poor HIV care outcomes. Patient navigation (care coordination with case management) and the use of financial incentives for achieving predetermined outcomes are interventions increasingly promoted to engage patients in substance use disorders treatment and HIV care, but there is little evidence for their efficacy in improving HIV-1 viral suppression rates. OBJECTIVE To assess the effect of a structured patient navigation intervention with or without financial incentives to improve HIV-1 viral suppression rates among patients with elevated HIV-1 viral loads and substance use recruited as hospital inpatients. DESIGN, SETTING, AND PARTICIPANTS From July 2012 through January 2014, 801 patients with HIV infection and substance use from 11 hospitals across the United States were randomly assigned to receive patient navigation alone (n = 266), patient navigation plus financial incentives (n = 271), or treatment as usual (n = 264). HIV-1 plasma viral load was measured at baseline and at 6 and 12 months. INTERVENTIONS Patient navigation included up to 11 sessions of care coordination with case management and motivational interviewing techniques over 6 months. Financial incentives (up to

Relationship Power and Sexual Risk among Women in Community-Based Substance Abuse Treatment

1160) were provided for achieving targeted behaviors aimed at reducing substance use, increasing engagement in HIV care, and improving HIV outcomes. Treatment as usual was the standard practice at each hospital for linking hospitalized patients to outpatient HIV care and substance use disorders treatment. MAIN OUTCOMES AND MEASURES The primary outcome was HIV viral suppression (≤200 copies/mL) relative to viral nonsuppression or death at the 12-month follow-up. RESULTS Of 801 patients randomized, 261 (32.6%) were women (mean [SD] age, 44.6 years [10.0 years]). There were no differences in rates of HIV viral suppression versus nonsuppression or death among the 3 groups at 12 months. Eighty-five of 249 patients (34.1%) in the usual-treatment group experienced treatment success compared with 89 of 249 patients (35.7%) in the navigation-only group for a treatment difference of 1.6% (95% CI, -6.8% to 10.0%; P = .80) and compared with 98 of 254 patients (38.6%) in the navigation-plus-incentives group for a treatment difference of 4.5% (95% CI -4.0% to 12.8%; P = .68). The treatment difference between the navigation-only and the navigation-plus-incentives group was -2.8% (95% CI, -11.3% to 5.6%; P = .68). CONCLUSIONS AND RELEVANCE Among hospitalized patients with HIV infection and substance use, patient navigation with or without financial incentives did not have a beneficial effect on HIV viral suppression relative to nonsuppression or death at 12 months vs treatment as usual. These findings do not support these interventions in this setting. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01612169.

Substance Use and High Risk Sexual Behaviors among Women in Psychosocial Outpatient and Methadone Maintenance Treatment Programs

Relationship power has been highlighted as a major factor influencing women’s safer sex practices. Little research, however, has specifically examined relationship power in drug-involved women, a population with increased risk for HIV transmission. Using baseline data from a National Institute on Drug Abuse Clinical Trials Network multisite trial of a women’s HIV prevention intervention in community-based drug treatment programs, this paper examined the association between sexual relationship power and unprotected vaginal or anal sex. The Sexual Relationship Power Scale, a measure of relationship control and decision-making dominance, was used to assess the association between power and unprotected sex in relationships with primary male partners. It was hypothesized that increased relationship power would be associated with decreased unprotected sexual occasions, after controlling for relevant empirical and theoretical covariates. Findings show a more complex picture of the association between power and sexual risk in this population, with a main effect in the hypothesized direction for decision-making dominance but not for relationship control. Possible explanations for these findings are discussed, and future research directions for examining power constructs and developing interventions targeting relationship power among drug-involved women are suggested.

Gender Research in the National Institute on Drug Abuse National Treatment Clinical Trials Network: A Summary of Findings

Objectives: The purpose of the present study was to assess the association between substance use/diagnosis and sexual risk behaviors among women enrolled in both psychosocial outpatient (PS) and methadone maintenance (MM) treatment and involved in a HIV prevention intervention study within the National Institute for Drug Abuse Clinical Trials Network. Methods: 515 sexually active women reported on unprotected sexual occasions (USO), anal sex, sex trading, sex with drug occasions, and multiple male sex partners at the baseline assessment. Results: Within the PS sample, cocaine use diagnosis was associated with more than twice the risk of having multiple partners, trading sex for drugs, having anal sex, or having sex with drugs; alcohol or opioid use diagnosis was associated with fewer risk behaviors. Within the MM sample, cocaine use, alcohol use and opiate use diagnoses were each associated with one to two risk behaviors. Associations between sexual risk and substance using days were less frequent in both samples. Conclusions: These findings highlight the need for integration of HIV sexual prevention interventions that address the relationship between sexual risk behavior and substance use diagnoses into substance abuse treatment programs.