HERMITAGE—a randomized controlled trial to reduce sexually transmitted infections and HIV risk behaviors among HIV‐infected Russian drinkers

Abstract

Aims This study assessed the effectiveness of HERMITAGE (HIV’s Evolution in Russia - Mitigating Infection Transmission and Alcoholism in a Growing Epidemic), an adapted secondary HIV prevention intervention, compared with an attention control condition in decreasing sexually transmitted infections (STIs) and sex and drug risk behaviors among Russian HIV-infected heavy drinkers. Design We conducted a single-blinded, two-armed, randomized controlled trial with 12-month follow-up. Setting The study was conducted in St. Petersburg, Russia. Participants were recruited from four HIV and addiction clinical sites. The intervention was conducted at Botkin Infectious Disease Hospital. Participants HIV-infected persons with past 6-month risky sex and heavy alcohol consumption (n=700) were randomized to the HERMITAGE intervention (n=350) or an attention control condition (n=350). Intervention A Healthy Relationships Intervention stressing disclosure of HIV serostatus and condom use, adapted for a Russian clinical setting with two individual sessions and three small group sessions. Measurements The primary outcome was incident STI by laboratory test at 12-month follow-up. Secondary outcomes included change in unprotected sex and several alcohol and injection drug use (IDU) variables. Findings Participants had the following baseline characteristics: 59% male, mean age 30, 60% past year IDU, 15.4% prevalent STI and mean CD4 cell count 413/μl. Assessment occurred among 75% and 71% of participants at 6 and 12-months, respectively. STIs occurred in 20 subjects (8%) in the intervention group and 28 subjects (12%) in the control group at 12-month follow-up; logistic regression analyses found no significant difference between groups (adjusted odds ratio 0.69; 95% CI: 0.36-1.30; P=0.25). Both groups decreased unsafe behaviors, although no significant differences between groups were found. Conclusions The HERMITAGE HIV risk reduction intervention does not appear to reduce sexually transmitted infections and HIV risk behaviors in Russian HIV-infected heavy drinkers compared with attention controls.

Alcohol Use, Partner Characteristics, and Condom Use Among HIV-Infected Russian Women: An Event-Level Study

“…Further, in the only intervention trial for HIV-infected Russian drinkers, there was limited evidence of the intervention's efficacy to reduce incident STI or HIV transmission risk behaviors relative to an attention-control group (Samet et al, 2015). Given our findings pertaining to male partner alcohol use and engagement in unprotected sex, future interventions for HIV-infected Russian women may benefit from couples-based approaches and inclusion of content addressing the intersection of alcohol use and unprotected sex.…”

Preventing blood-borne virus infection in people who inject drugs in the UK: systematic review, stakeholder interviews, psychosocial intervention development and feasibility randomised controlled trial

“…Incomplete outcome data was the most common risk of bias found in the trials included in the review, but selective outcome reporting also contributed to potential risk of bias for some trials. Other potential sources of bias included altering randomisation protocols depending on the number of participants enrolled on a particular day; 182 statistically significant differences between groups at baseline in the injecting subscale; 173 variation in the TAU group across sites; 68 possible crossover contamination between groups; 69,75,179,180,182,194 a high proportion of excluded individuals with the excluded individuals differing significantly to those included; 71 and large variations reported in the follow-up period. …”

“…In total, 12,840 participants (35% female, range 0-100%) were enrolled in the trials; the majority were PWID (84.5%) (the proportion of participants enrolled in the trials who were PWID ranged from 16% to 100%). The majority (n = 18) of trials were conducted in the USA, 22,68,[70][71][72]76,81,84,174,176,177,179,182,186,189,193,195,196 three were conducted in Russia, 74,75,194 two were conducted in Canada, 175,178 two were conducted in Vietnam, 82,180 one was conducted in Kazakhstan, 73 one was conducted in Georgia, 188 one was conducted in Australia, 197 one was conducted in the UK, 173 one was conducted in Mexico, 77 one was conducted in Puerto Rico 192 and one was conducted in both the USA and Thailand. 69 Trials included in the systematic review compared psychosocial interventions with usual care (n = 4), 22,68,178,195 education or information (n = 9), 70,76,77,175,176,180,188,…”

“…84,177 The remaining eight trials delivered interventions in more than one way (e.g. individual and couples sessions, 187,188 individual and group sessions, 69,76,186,190,194 Records identified from electronic database searches ( Samet 2015 194 Rotheram-Borus 2010 193 Robles 2004 192 Purcell 2007 189 Otiashvili 2012 188 McMahon 2013 84 Margolin 2003 Hoffman 2013 74 Go 2015 82 Go 2013 180 Gilbert 2010 73 Garfein 2007 179 Gagnon 2010 178 El-Bassell 2011 177 Dushay 2001 ) and one trial provided both individual-and structural-level activities. 82 For interventions with more than one session, retention or adherence to the intervention ranged from 50% 68 to 95%.…”

“…81 Eight interventions incorporated peer mentoring from an index participant to change the behaviours of other PWID. 69,72,74,76,179,180,182,190 The majority of interventions contained at least three sessions (n = 25), 22,[69][70][71][72][73][74]76,81,82,173,174,[176][177][178][179][180]182,186,188,190,[192][193][194]196,197 four interventions contained two sessions, 68,75,187,195 and three interventions contained only one session. 77,175,197 Most interventions were delivered in drug treatment settings, including outpatient and hospital clinics, 71,72,173,[192][193]…”