Search the Library

Abstract: Receptive anal sex has high human immunodeficiency virus (HIV) transmission risk, and heterosexual substance-abusing individuals report higher anal sex rates compared to their counterparts in the general population. This secondary analysis of two NIDA Clinical Trials Network studies (CTN-0018 and CTN-0019) evaluated the effectiveness of two gender-specific, evidence-based HIV prevention interventions (Real Men are Safe, or REMAS, for men; Safer Sex Skill Building, or SSSB, for women) against an HIV education (HIV-Ed) control condition on decreasing unprotected heterosexual anal sex (HAS) among substance abuse treatment-seeking men (n=171) and women (n=105). Two variables, engagement in any HAS and engagement in unprotected HAS, were assessed at baseline and three months post-intervention. Compared to the control group, women in the gender-specific intervention did not differ on rates of any HAS at follow-up but significantly decreased their rates of unprotected HAS. Men in both the gender-specific and the control interventions reported less HAS and unprotected HAS at three-month follow-up compared to baseline, with no treatment condition effect. Conclusions: Women and men showed different patterns when it came to unprotected HAS. For men, rates of unprotected HAS decreased overall in the sample, and patterns suggest the reduction may, at least partly, reflect their decreased rates of engaging in any HAS. On the other hand, SSSB women did show a decrease in unprotected HAS compared to controls despite no significant difference in overall HAS rates. For them, the results suggest the SSSB intervention did produce intentional action toward risk reduction. The mechanism of action for SSSB compared to REMAS in decreasing unprotected HAS is unclear. More attention to HAS in HIV-prevention interventions for heterosexual men and women in substance abuse treatment is warranted. Related protocols: CTN-0018, CTN-0019

Abstract:

This Blending Team Product combines a CME course and Patient Simulation to create a unique forum to provide practical guidance for physicians and other clinicians in effective Motivational Interviewing techniques that will facilitate conversations with patients to address health risk behaviors. The CME course, “Talking to Patients about Health Risk Behaviors,” guides physicians, nurses, and other clinicians through practical skills building and technique development using videos to model effective communication, while the interactive Patient Simulation allows for real time testing and reinforcement of these skills in the clinical setting.

Physicians can earn a maximum of 1.5 AMA PRA Category 1 Credits via the CME course; Nurses can earn 1.5 ANCC Contact Hours. There is also an unaccredited module for other providers to use to enrich their clinical best practices.

Abstract:

The “Real Men Are Safe-Culturally Adapted” (REMAS-CA) study was an outgrowth of the National Drug Abuse Treatment Clinical Trials Network protocol CTN-0018, which developed and evaluated Real Men Are Safe (REMAS), a safer sex skills training intervention for men in substance abuse treatment. The study aimed to develop an adherence scale for REMAS-CA, a modified version of the original REMAS intervention tailored for African Americans and Hispanics, measure improvement in counselors’ intervention delivery skills over time, and identify which modules of the new adapted intervention were hardest to deliver. REMAS-CA was piloted in four addiction treatment programs, with two counselors per site running 3 or 4 rounds of REMAS-CA groups over about 9 months. Group recordings were reviewed by a team of four (lead- and co-investigator plus two undergraduates) for 1) manual adherence, 2) avoidance of proscribed behaviors, 3) global empathy and co-therapy. Inter-rater reliability was calculated for all raters, and adherence and skill scores were compared for counselors’ first and last cohorts using paired t-tests.

Results found that counselors did not improve delivery of REMAS-CA over time, except in global empathy, which showed significant improvement from first cohort to last. Discussions of current and past relationships, and role plays of communication skills with partners, were most difficult for counselors.

Conclusions: A highly reliable system for rating counselor skill and adherence to REMAS-CA was developed for this study. Counselors’ lack of significant improvement in skill, co-therapy, global empathy, and avoidance of proscribed behaviors may have been because they scored relatively high even in their first round of intervention delivery. Results suggest that the 2-day training and subsequent certification process, manual structure, and early supervision may have solidified counselors’ skills, leaving little “room for improvement.”

Related protocols: CTN-0018

Abstract:

High-risk sexual behavior is an important vector of the HIV/AIDS epidemic, particularly among female substance abusers. Effective interventions to reduce unprotected sexual occasions (USO) and increase condom skills in this population are needed. Literature suggests ethnicity may influence risk behavior and participant response to intervention. This poster describes a secondary analysis of a gender-specific controlled multi-site trial of a 5-session HIV/STD risk reduction intervention for women, Safer Sex Skills Building (SSB), compared to a 1-session Health Education (HE) control (National Drug Abuse Treatment Clinical Trials Network protocol CTN-0019). SSB was skills-oriented but not ethnically tailored. Based on literature, it was hypothesized that ethnicity would moderate the intervention effects of SSB, reducing USO and increasing condom use skills among Caucasians but not minorities. For the primary outcome (unprotected sexual occasions), results found a significant main effect of treatment, reflecting lower USO in the SSB group, but no ethnicity by treatment interaction. For male condom use skills, there was an interaction between ethnicity and time, reflecting significantly greater skills among minorities at the 6-month follow-up. For female condom use skills, there was an interaction between ethnicity and treatment, reflecting significantly higher skills among minorities in the SSB group.

Conclusions: Contrary to the original hypothesis, a skills-based HIV risk reduction intervention was equal to or more effective among minorities in reducing unprotected sexual occasions and increasing condom use skills.

Related protocols: CTN-0019

Abstract:

The presentation reports on a study designed to revise the CDC recognized, evidence-based HIV prevention intervention, “Real Men Are Safe” (REMAS) to be more culturally relevant to African American and Hispanic men, and then conduct a pilot feasibility trial of the revised REMAS (REMAS-CA) in four CTN community treatment providers that have a high percentage of minority clients. Comparisons between the original REMAS manual and four culturally tailored interventions (Nia, d-up, Many Men Many Voice, and Cuidate) were made, focusing in particular on language/expressions of the target group; activities that enhance ethnic identity, consistency with the norms, knowledge, and cultural values of the target group; and understanding of the social context and living situations of the target group. Resultant changes to the original intervention are described, along with data and feedback from focus groups following pilot testing of the REMAS-CA.

Related protocols: CTN-0018

Abstract:

Data indicates that substance use may play a role in over 50% of HIV infections through high risk heterosexual contact, injection drug use, and in cases with combined risk. Drug-involved women are at especially high risk for heterosexual transmission of HIV, as primary male partners often use drugs and their own substance use may impair decision-making and decrease perception of risk. Brief, didactic interventions have been insufficient in reducing sexual risk behaviors. The CTN’s “Safer Sex for Women Study” (CTN-0019) offered an opportunity to test a multi-session, gender-specific, efficacious treatment against a single HIV education prevention session in a large effectiveness trial. Eligible participants reported at least one unprotected sexual occasion (USO) with a male partner in the 6 months prior to enrollment and were not pregnant or planning a pregnancy. Women were randomized to a 5-session Safer Sex Skills Building group (SSB) or a 1-session HIV Education group (HE). Participants were assessed at baseline and 3- and 6-months post treatment. Primary analysis revealed a significant time by intervention interaction whereby both interventions produced reductions in USO at 3-month follow-up, but SSB further reduced USO at 6-month follow-up while women in HE returned to baseline levels. Secondary analysis showed a significant treatment by time interaction for sex while intoxicated. Evidence-based HIV prevention should be integrated into substance abuse treatment programs; however, current policy limitations and practice demands make this challenging. Further, contextual factors, such as trauma history, are important to understanding sexual behaviors that increase HIV risk. Social workers are well positioned to advocate for best practices in clinical settings and for state and local policies that enhance quality of care. Thus, social workers can and should be key collaborators in the research conducted within the CTN to maximize the impact within community-based treatment settings.

Related protocols: CTN-0019

Abstract:

This is the primary outcomes paper for CTN-0020.

Unemployment is associated with negative outcomes both during and after drug abuse treatment. Interventions designed to increase rates of employment may also improve drug abuse treatment outcomes. The purpose of this multi-site clinical trial, protocol CTN-0020, was to evaluate the Job Seekers’ Workshop (JSW), a three-session, manualized program designed to train patients in the skills needed to find and secure a job. Study participants were recruited through the National Drug Abuse Treatment Clinical Trials Network (CTN) from six psychosocial counseling (n=327) and five methadone maintenance (n=301) drug treatment programs. Participants were randomly assigned to either standard care (program-specific services plus brochure with local employment resources) (SC) or standard care plus JSW. Three 4-h small group JSW sessions were offered weekly by trained JSW facilitators with ongoing fidelity monitoring. JSW and SC participants had similar 12- and 24-week results for the primary outcome measure (i.e., obtaining a new taxed job or enrollment in a training program). Specifically, one-fifth of participants at 12 weeks (20.1-24.3%) and nearly one-third at 24 weeks (31.4-31.9%) had positive outcomes, with “obtaining a new taxed job” accounting for the majority of cases.

Conclusions: JSW group participants did not have higher rates of employment/training than SC controls. Rates of job acquisition were modest for both groups, suggesting more intensive interventions may be needed. Alternate targets (e.g., enhancing patient motivation, training in job-specific skills) warrant further study as well. Secondary analyses of present study findings will examine potential mediators and moderators of study outcomes, with a focus on barriers to employment and other variables.

Related protocols: CTN-0020

Abstract:

The female condom is effective in reducing unprotected sexual acts; however it remains underutilized in the U.S. This study, part of the National Drug Abuse Treatment Clinical Trials Network protocol CTN-0019 (“Reducing HIV/STD Risk Behaviors: A Research Study for Women in Drug Abuse Treatment”), examined whether a 5-session HIV prevention intervention (Safer Sex Skills Building (SSB)), including presentation, discussion, and practice with female condoms, improved female condom skills and attitude among women in outpatient substance abuse treatment. Mixed-effects modeling was used to test the effect SSB on skills and attitude over 3- and 6-month post-treatment among 515 randomized women. SSB was significantly associated with increases in skills and attitude, and the female condom demonstration session was primarily responsible for skills improvement. Attitude was a partial mediator of the intervention effect in reducing unprotected sex.

Findings emphasize the utility of integrating female condom messages targeting proximal behavioral outcomes into HIV prevention. Female condoms should be visible and available in treatment programs and other places women frequent and discussion about female condoms should be integrated into group and individual counseling. This study supports the importance of brief, hands-on exercises for female condom skill instruction, as well as further research to enhance attitudinal change to reduce sexual risk.

Related protocols: CTN-0019

Abstract:

This poster reports on a study designed to revise the CDC recognized, evidence-based HIV prevention intervention, “Real Men Are Safe” (REMAS) to be more culturally relevant to African American and Hispanic men, and then conduct a pilot feasibility trial of the revised REMAS in four CTN community treatment providers that have a high percentage of minority clients. The Delphi Process was used to modify the intervention, with expert panel members reviewing and rating all the modules from REMAS and four other HIV prevention interventions tailored to minority men. Panel members also provided specific suggestions of ways to revise REMAS to make it more culturally sensitive. After round 1, the manual was revised and then rated again by the expert panel in round 2. Following round 2, the final version, REMAS-CA (“culturally adapted”) was completed and readied for pilot testing.

The Delphi Process was found to be a successful technique for the revision process, and though the quantitative ratings and qualitative suggestions were, for the most part, consistent with each other, the qualitative feedback was utilized more extensively in making revisions to REMAS (specific revisions are noted in the poster). The effectiveness of the REMAS-CA at decreasing high risk sexual behavior of African American and Hispanic men in substance abuse treatment is currently undergoing pilot testing.

Abstract:

This workshop provides an overview of protocol CTN-0019, “Reducing HIV/STD Risk Behaviors: A Research Study for Women in Drug Abuse Treatment,” which compared a one-session HIV health education intervention (HE) to a five session, gender-specific HIV risk reduction intervention for women in substance abuse community treatment programs (Project WORTH). The study found a significant difference in mean unprotected sexual occasions between the 5 session skills building intervention and the single-session health education session. At three months, significant decrements were observed in both groups, but at six months, while those in Project WORTH had maintained that decrement, those in health education had returned to baseline. Women in WORTH also had 29% fewer unprotected sexual occasions than those in HE. The gender-specific, skills building intervention developed by this protocol is both effective and sustainable in reducing risk behavior in women in community drug treatment programs.

Related protocols: CTN-0019

Abstract:

This presentation describes Project WORTH, a five-session, gender-specific HIV risk reduction intervention used in protocol CTN-0019 (“Reducing HIV/STD Risk Behaviors: A Research Study for Women in Drug Abuse Treatment”). The goal of this intervention is to help women change behaviors that put them at risk of becoming infected with HIV or other sexually transmitted diseases, and to help them live healthier lifestyles. The intervention is based on social cognitive learning theory and empowerment theory, and uses skills-building procedures that include discussion, modeling, role-playing, and problem solving. This presentation describes each session of Project WORTH, including its objectives and techniques.

CTN-0019 found that the Project WORTH intervention was effective and sustainable in reducing risk behavior in community drug treatment programs.

Related protocols: CTN-0019

Abstract:

This presentation, developed for clinicians, provides an overview of protocols CTN-0018 and CTN-0019, “Reducing HIV/STD Risk Behaviors: A Research Study for Men/Women in Drug Abuse Treatment.” It describes in detail the interventions evaluation by the two protocols, “Real Men Are Safe (REMAS)” (men) and “Safer Sex Skills Building (SSSB)” (women), presenting the main findings from each study, as well as a demonstration of part of the women’s program.

Both programs were associated with greater sexual risk reduction in men and women, suggesting that substance abuse treatment programs can help reduce sexual risk among their patients by providing not only information but also hands-on practice skills.

Related protocols: CTN-0018, CTN-0019

Abstract:

Since women in high drug use communities are among the fastest growing groups with AIDS, sexual risk reduction interventions for drug-using women is a public health imperative. A randomized controlled trial of evidence-based, gender-specific HIV/STD safer skills building (SSB) group versus standard HIV/STD education (HE) was conducted with women in 12 community drug treatment programs in NIDA?s Clinical Trials Network (protocol CTN-0019). Based on social cognitive learning theory and empowerment theory, SSB consisted of 5 group sessions, using problem solving, skill rehearsal and peer support to increase HIV/STD risk awareness/skills, especially condom use and partner negotiation. As previously reported, reduction in the primary outcome, frequency of unprotected (vaginal or anal) sexual occasions (during the prior 3 months), was observed in both conditions at 3 months; however, at 6 months, whereas this decline held in the SSB condition, there was an increase in the HE condition, reflecting a significant time by intervention condition difference (F=67.2, p<.0001). Intervention effects on the secondary outcomes, of carrying condoms (versus not) and perceived self-efficacy to use condoms, will be presented. For both analyses, 515 women were included in intention-to-treat mixed effect modeling. A significant Intervention X Time effect was obtained in probability of carrying a condom ? with the SSB group showing a significant increase in probability at 3 months (F=8.58, p<.004) and at 6 months (F=4.98, p<.03), as compared to the HE group, for whom these probabilities were unchanged. The Intervention X Time effect for self-efficacy to use condoms only obtained a trend toward significance at 6-months (F=3.6, p<.06). The implications of these findings for conceptualizing behavior change achieved during sexual risk reduction intervention among drug-using women will be discussed. The finding of a significant intervention effect, favoring the SSB condition, on carrying condoms provides support for the effect previously reported for the primary outcome of frequency of unprotected sexual occasions. The finding of an only trend-level intervention effect on perceived self-efficacy to use condoms raises some question about the influence of this construct in the behavior change observed.

Related protocols: CTN-0019

Abstract:

Since drug-involved women are among the fastest growing groups with AIDS, sexual risk reduction intervention for them is a public health imperative. The objective of this study, part of protocol CTN-0019 (“Reducing HIV/STD Risk Behaviors: A Research Study for Women in Drug Abuse Treatment”), was to test the effectiveness of HIV/STD safer sex skills building (SSB) groups for women in community drug treatment. The study used a randomized trial of SSB versus standard HIV/STD Education (HE), with assessments at baseline, 3, and 6 months. Women were recruited from 12 methadone or psychosocial treatment programs in the National Drug Abuse Treatment Clinical Trials Network. Five hundred and fifteen women who had had at least one unprotected vaginal or anal sex occasion (USO) with a male partner in the past six months were randomized. 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.

The main outcome measured was the number of USOs at follow-up. 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. This study demonstrates that skills building interventions can produce ongoing sexual risk reduction in women in community drug treatment.

Related protocols: CTN-0019