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Table 2 Summary of study characteristics of controlled trials

From: Sexual health risk reduction interventions for people with severe mental illness: a systematic review

Study, year Setting and location Populationa Intervention Control Outcomes measured Follow up
Berkman et al. 2006, [25,27]b Homeless shelter, New York, USA Sample size: 92 Social skills training approach with cognitive-behavioral theory (6 sessions). Details unclear on who delivered the intervention. Standard HIV (1 session) education (n = 42; of which 23 sexually active) Unprotected anal, vaginal, oral sex with casual partners (women or men) as measured by VEE scorec 6 months
Mean age: 38 years
Male: 100%
Diagnosis: Schizophrenia or schizoaffective disorder, 72%; bipolar disorder, 3%; major depressive disorder, 10% Intervention included videos, role-playing activities for development of skills, condom use skills, negotiating safer sex, behavior change, education on risks and problem solving skills (n = 50; of which 33 sexually active)   
Ethnicity: African-American, 65%
Berkman et al. 2007,[26] Outpatient psychiatric clinics, New York, USA Sample size: 149 Social skills training approach with cognitive-behavioral theory (10 sessions with boosters at 3, 6 and 9 months) delivered by substance abuse and/or mental health counsellors. Money-management with matched treatment for dosage and format of the intervention group (n = 76) Unprotected anal, vaginal, oral sex with casual partners (women or men) as measured by VEE scorec 12 months
Mean age: NR
Male: 100%
Diagnosis: Schizophrenia, 49%; schizoaffective disorder, 22.8%; bipolar disorder, 9.4%; major depressive disorder, 5.4% Intervention included role-playing activities for development of skills, condom use skills, negotiating and practising safer sex (e.g. ethics, goals, commitment), behavior change, education on risks and problem solving skills (n = 73)   
Ethnicity: African-American, 53.7%    
Carey et al. 2004,[28]b Outpatient psychiatric clinics, New York, USA Sample size: 408 HIV risk reduction programme (10 sessions) including enhancing knowledge about HIV transmission, and prevention, motivation for behavior change and strengthening behavioral skills and self-management training (n = 142) Standard care which included HIV and substance use education, if needed (n = 126) Frequency of unprotected vaginal sex, total number of sex partners, total number of casual partners, number of safer sex communications before intercourse and self-report of STIs 6 months
Mean age: 36.5
Male: 46%
Diagnosis: Schizophrenia, 18%; schizoaffective disorder, 15%; bipolar disorder, 19%; major depressive disorder, 49%
Ethnicity: African-American, 21% Substance use reduction programme (10 sessions) including enhancing knowledge, motivation and skills to reduce caffeine consumption, smoking, and alcohol use (n = 140)   
  All interventions delivered by trained clinical facilitators (with weekly supervision from a licensed clinical psychologist).   
Collins et al. 2011, [29] Urban community setting, New York, USA Sample size: 79 HIV prevention programme with social cognitive theory (10 sessions) delivered by trained facilitators (no further details provided). Money-management (10 session workshop on managing finances and last through the month) (n = 40) Unprotected anal, vaginal, oral sex with sexual partners (casual, steady, exchange) as measured by VEE scorec 6 months
Mean age: 42.3
Male: 0%
Diagnosis: Schizophrenia, 50%; schizoaffective disorder/ psychosis not specified, 14%; mood disorder with psychosis, 13%; mood disorder without psychosis, 23% Intervention focus was on self-efficacy and skills training and included HIV/STI awareness, risk prevention, self-assertiveness, negotiating and practising safer sex, condom use skills; problem solving skills and commitment to self-protection (n = 39)   
Ethnicity: Black, 61%    
Kalichman et al. 1995, [30]b Outpatient psychiatric community care, Wisconsin, USA Sample size: 52 HIV prevention programme based on behavioral skills training (4 sessions) delivered by trained facilitators experienced in HIV risk reduction interventions. Waiting list group (who later received the intervention) (n = 29) Knowledge, condom use, behavior change interventions 2 months
Mean age: 39.2
Male: 52%
Diagnosis: Schizophrenia, 62%; schizoaffective disorder, 23%; major affective disorder including bipolar, 13% Intervention included education on risk reduction, sexual assertiveness, negotiation skills (risk-related behavioral self-management), condom use and problem-solving skills (n = 23)   
Ethnicity: African-American, 19%  
Katz et al. 1996,[31]b Outpatient psychiatric centre, California, USA Sample size: 27 AIDS education and risk reduction training programme (4 sessions). Details unclear on who delivered the intervention. No treatment (n = 12) Knowledge, behavior change interventions 2 weeks
Mean age: NR
Male: NR but male female ratio 2:1
Diagnosis: NR but majority of patients diagnosed with schizophrenia and bipolar disorder Intervention included education about HIV and AIDS, refusal skills training and problem solving skills (n = 15)   
Ethnicity: NR    
Kelly et al. 1997,[32]b Outpatient psychiatric care, Wisconsin, USA Sample size: 104 Cognitive-behavioral therapy (7 sessions) that focused on behavior changes to reduce the risk of contracting HIV. Interventions included education on risk reduction, sexual assertiveness, negotiation skills (risk-related behavioral self-management), condom use and problem-solving skills (n = 34) A single 60 minute AIDS education session (n = 28) AIDS risk behavior (knowledge and safer-sex practices), and condom use: barriers to behavior change and perceived risk reduction, self-efficacy for use 3 months
Mean age: 33.7
Male: 47%
Diagnosis: Schizophrenia, 19%; mood disorder, 58%; anxiety disorder, 11%; substance use or personality disorder, 11%
Ethnicity: African-American, 39% Cognitive-behavioral therapy (7 sessions) combined with advocacy training (to act as a risk reduction advocate to their friends and acquaintances) (n = 42)   
  All interventions delivered by facilitators (no further details provided)   
Linn et al. 2003,[33]b Homeless shelter, Nashville, USA Sample size: 257 Social skills training approach with cognitive-behavioral theory (6 sessions) delivered by HIV educators, a mental health professional and a ‘paraprofessional’. HIV and STI information (6 sessions) and basic instruction on condom use (n = 127) Unprotected anal, vaginal, oral sex with casual, occasional and regular partners (women or men) as measured by VEE scorec 6 months
Mean age: NR
Male: 100%
Diagnosis: Schizophrenia/schizoaffective disorder, 61%; major depression/ bipolar disorder, 26%; other, 14% Intervention included Sex, Games and Videotapes with storytelling, competitive games and acting scenes with true to life scenarios (n = 130)   
Ethnicity: African-American, 54%    
Malow et al. 2012, [34]b Outpatient psychiatric clinics, Florida, USA Sample size: 290 Enhanced cognitive behavioral skill building programme (6 sessions) delivered by trained facilitators (no further details provided). Health promotion including provision of information on HIV, heart attacks, good food habits, exercise, smoking and stress (n = 126) HIV knowledge, perceived susceptibility, AIDS related anxiety, personal condom attitudes, peer and partner sexual attitudes, condom use skills, sexual self-efficacy, total number of unprotected vaginal sex acts, proportion of unprotected vaginal sex acts, total number of sex partners. 6 months
Mean age: 39.6
Male: 45%
Diagnosis: schizophrenia, 15.7%; schizoaffective disorder, 8.4%; bipolar disorder, 9.6%; major depressive disorder, 21.2% Intervention included HIV education, condom use, safe sex, high risk situations, and communication skills (n = 164)  
Ethnicity: African-American, 55%   
NIMH 2006,[37]b Outpatient mental health clinics, New York and Los Angeles, USA Sample size: 99 Living in good health together programme (7 sessions) delivered by trained facilitators (no further details provided). A single AIDS education session including video, discussion, and referral information (n = 47) Number of partners; number of risky sexual acts, proportion of condom use; consistent condom use 12 months
Mean age: NR
Male: 100%
Diagnosis: NR but patients with schizophrenia and bipolar disorder were eligible Small group interventions covered knowledge of HIV, personal triggers for risk behavior, problem solving skills, condom use, assertiveness, negotiation strategies and relapse prevention (n = 52)   
Ethnicity: African-American, 72.4%    
Otto-Salaj et al. 2001, [35]b Outpatient mental health clinics, Wisconsin, USA Sample size: 189 HIV prevention programme (7 sessions with boosters at 1 and 2 months later) delivered by trained mental health facilitators. Health promotion including educational discussion and skills building exercises (focused on personal relationships, stress, nutritional health, cancer, heart disease and general sexual health) (n = NR) HIV risk knowledge, attitudes towards condom use; risk reduction behavioral intentions; frequency of protected and unprotected intercourse; intercourse occasions protected by condoms; number of partners; 12 months
Mean age: 38.4
Male: 46%
Diagnosis: Schizophrenia, 35%; affective disorder, 34%; schizoaffective disorder, 18%; other, 13% Intervention included HIV risk reduction, condom use, problem solving strategies, discussion and role-play, negotiation and assertiveness skills and behavior change (n = NR)
Ethnicity: African-American, 51%    
Susser et al. 1998, [36] Homeless men, New York, USA Sample size: 59 (sexually active) Social skills training approach with cognitive-behavioral theory (15 sessions) delivered by a mental health professional and a ‘paraprofessional’. Health promotion (2 sessions) including provision of information on HIV, STI and condom use (n = 26) Unprotected anal, vaginal, oral sex with casual and occasional partners (women or men) as measured by VEE scorec 18 months
Mean age: NR
Male:100%
Diagnosis: Schizophrenia/schizoaffective disorder, 61%; major depression/ bipolar disorder, 27%; other, 12% Intervention included Sex, Games and Videotapes with storytelling, competitive games and acting scenes with true to life scenarios (n = 33)   
Ethnicity: African-American, 58%    
Weinhardt et al. 1998, [38]b Outpatient psychiatric care, New York, USA Sample size: 20 Sexual assertiveness programme (10 sessions) delivered by a facilitator (no further details provided) No treatment (n = 11) Sexual assertiveness, knowledge, motivation, HIV risk behavior 4 months
Mean age: 36
Male: 0%
Diagnosis: Schizophrenia spectrum disorders, 50%; bipolar disorder, 30%; major depressive disorder, 20% Intervention included HIV related information and risk-behavior reduction, skill acquisition and fluency building and generalization of skills to actual interactions (n = 9)   
Ethnicity: NR    
  1. NR, not reported; STI, sexually transmitted infections; VEE, vaginal episode equivalent.
  2. aCharacteristics at baseline.
  3. bAlthough all studies were described as RCTs by the study authors, this study did not report the method of randomization. According to the EPHPP quality assessment tool, this study would be categorized as a controlled clinical trial.
  4. cThe VEE score is a sexual behavior risk index. It is calculated using the following formula: (number of unprotected vaginal episodes) + (2 X number of unprotected anal episodes) + (0.1 X number of unprotected oral episodes). The VEE can be refined when data are extensive. For further details see Susser et al. [39].