Introduction
Methods
Results
Non-gender Studies
Citation | Population/country | Study arms | Alcohol use outcome measures | Viral load outcome measures | Findings |
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Edelman et al., 2019a [21] | N=128 (97.5% male, 78.9% Black) Veterans living with HIV who met DSM-IV criteria for AUD; multisite trial; USA | Intervention: ISAT Interventions: Brief Negotiated Interview; 4 individual sessions of psychologist-delivered Motivational Enhancement Therapy + Medication-Assisted Treatment; Stepped treatment over 24 weeks Standard of Care: Annual screening via AUDIT-C; Brief interventions or referral to addiction treatment and health handouts | • Percentage of days abstinent (TLFB) • PEth blood levels (DBS) • Past 30-day abstinence (TLFB) • Drinks per week (TLFB) • Percentage of participants with no heavy drinking days (men: >5 drinks/day; women: >4 drinks/day; TLFB) • Mean number of drinks per drinking day (TLFB) | • Undetectable plasma HIV viral load (HIV RNA <50 copies/ml) | • At 24- and 52-week follow-up: Both study arms reported increased alcohol abstinence; No significant differences in alcohol use or viral load outcomes between study arms |
Edelman et al., 2019b [62] | N=95 (99% male; 85% Black) Veterans living with HIV and liver disease who consumed alcohol in the past 30 days; multisite trial; USA | • At 24- and 52-week follow-up: Both study arms reported increased alcohol abstinence; No significant differences in alcohol use or viral load outcomes between study arms | |||
Edelman et al., 2020 [61] | N=93 (97% male; 78.7% Black) Veterans living with HIV at risk for alcohol use; multisite trial; USA | • At 24- and 52-week follow-up: Both study arms reported increased alcohol abstinence; No significant differences in alcohol use or viral load outcomes between study arms | |||
Go et al., 2020 [63] | N=440 (96.8% male) People living with HIV receiving ART and with hazardous alcohol use; Vietnam | Intervention: Combined intervention of culturally adapted Motivational Enhancement + Cognitive Behavioral Therapy; 6 individual face-to-face sessions and 3 optional group sessions Intervention: Culturally adapted Brief Alcohol Intervention; 2 face-to-face sessions and 2 booster telephone sessions Standard of Care: Recommendation to reduce alcohol use; referral to harm reduction services and treatment for HBV and HCV, STIs, and TB | • Self-reported percentage of days abstinent (TLFB) • Number of drinks per day (TLFB) • Heavy drinking days (defined as >4 drinks for men and >3 drinks for women; TLFB) | • Viral suppression (HIV RNA <20 copies/ml) | • At 3-, 6-, and 12-month follow-up, participants in both intervention arms reported a significantly larger increase in days of abstinence and a significantly lower number of heavy drinking days compared with participants in the SOC arm • Participants in the Brief Alcohol Intervention arm were more likely to be virally suppressed than participants in the SOC arm (89.2% vs. 78.1%) at 12-month follow-up • At 3- and 6-month follow-up, participants in both intervention arms reported significantly greater reductions in drinks per drinking day compared with participants in the SOC arm, and at 12-month follow-up, participants in the combined intervention arm reported significantly greater reductions in drinks per drinking day compared with participants in the SOC arm |
Madhombiro et al., 2020 [67] | N=234 (78.6% male) People living with HIV on ART who have an AUD; Zimbabwe | Intervention: MICBT; 8 to 10 individual sessions, lasting 45–60 min each Enhanced usual care: Alcohol-use module from the WHO Mental Health Gap intervention guide | • AUDIT score | • Adherence (percentage of scheduled visits for medication refills in the past 3 months) • Viral suppression (<40 copies/ml) • CD4 count | • Intervention participants had significantly greater reductions in AUDIT scores at 6-month follow-up compared with participants in the control group • Both study groups had a significant decrease in viral load, but no statistically significant difference between the study arms at 6-month follow-up • No statistically significant reduction in CD4 count within groups and/or between study arms at 6-month follow-up |
Stein et al., 2020 [66] | N=110 (81.8% male) People living with HIV or current or previous HCV infection and reported consuming at least 4 alcoholic drinks per week in the past month; USA | Intervention: REACH with motivational enhancement elements; 7 individual phone sessions, 20-30 min each, every 3 months for 18 months Intervention: Brief advice with 7-sessions about the HIV-HCV-related risks of alcohol use | • Drinking days (TLFB) • Number of drinks per day (TLFB) • Addiction Severity Index | • HIV RNA viral load | • Drinks per drinking day significantly reduced in both study groups, but reductions were not statistically significant between study groups • No statistically significant treatment effects for any alcohol use outcome • No HIV outcomes reported |
Satre et al., 2019 [65] | N=614 (96.9% male) People living with HIV who self-reported unhealthy alcohol use in the past year; USA | Intervention: Motivational Interviewing; one 45-min in-person individual session at the clinic followed by two 20-min telephone sessions Intervention: Email Feedback; one email sent via a secure patient portal messaging function Standard of Care: Routine HIV primary care; screening for unhealthy drinking based on NIH-recommended thresholds; referrals to specialty addiction services | • Number of drinking days in the past 30 days • Addiction Severity Index • Alcohol Importance Ruler, and Confidence Ruler | • Self-reported ART adherence • HIV RNA levels | • All arms demonstrated a statistically significant decrease in alcohol use outcomes, but no significant difference between arms • Among participants who reported that reducing drinking was of low importance (n=334), participants in the motivational interviewing arm were significantly less likely to have any heavy drinking days than participants in the SOC arm at 12-month follow-up |
Naar et al., 2020 [64] | N= 183 (79.2% male, 13.7% female, 7.1% transgender or gender nonconforming) adolescents (aged 16 to 24 years) living with HIV; 5 sites in USA | Intervention: Adapted Healthy Choices Intervention – Home: 4 30-min individual sessions over 10 weeks delivered at home or in community by a paraprofessional Intervention: Adapted Healthy Choices Intervention – Clinic: 4 30-min individual sessions over 10 weeks delivered in home by a paraprofessional | • Severity of problems (ASSIST) • Number of drinks per week (TLFB) | • Undetectable plasma HIV viral load (HIV RNA <20) | • Participants in the clinic delivery group maintained reductions in alcohol • The clinic delivery group had significantly greater reductions in viral load over each post-intervention follow-up |
Gender Studies
Citation | Population/setting | Study arms | Alcohol use outcome measures | Viral load outcome measures | Findings |
---|---|---|---|---|---|
Cook et al., 2019 [26] | N=194 Women living with HIV who reported consuming >7 drinks/week or >3 drinks on 1 day at least twice; USA | Intervention: Naltrexone pill taken orally once a day; 4 months Placebo | • The average number of drinks per week (TLFB) • Number of days of abstinence (TLFB) • Number of binge-drinking days in the past 30 days (TLFB) • PEth blood levels (DBS) | • Self-reported ART adherence • CD4+ cell count • Undetectable plasma HIV viral load (HIV RNA <200 copies/ml) | • Intervention participants had significantly lower levels of unhealthy drinking at 1-month and 3-month follow-up, but not at 4-month follow-up • No significant difference in odds of reducing or quitting drinking or other alcohol outcomes between study arms at follow-points • Adherence and viral load outcomes did not differ by group |
Huis in’t Veld et al., 2019 [68] | N=560 (53.9% male, 46.1% female) Adults with HIV-1 and who visited the 3 selected HIV clinics; South Africa | Intervention: Information-Motivation-Behavioral Skills Model-based intervention; Health education leaflet on responsible drinking Personalized feedback on AUDIT scores Brief counseling session on reducing excessive drinking; individual; 1 session Control: Health education leaflet on responsible drinking | • 10-item AUDIT | • CD4+ count; viral load • ART adherence | • Intervention and counseling session participants have a significant reduction in AUDIT scores; no significant difference between study groups • Intervention participants’ mean last measured CD4 count was significantly lower at time point 1 but not at time point 2 • Intervention did not influence other HIV outcomes |
Papas et al., 2021 [70] | N=614 (48.5% male) Adults enrolled as an AMPATH HIV outpatient with hazardous drinking; Kenya | Intervention: CBT intervention consisting of 6 weekly 90-min group sessions Healthy Life-styles (HL): educational intervention encouraging healthy lifestyle choices consisting of 6 weekly 90-min group sessions | • Percentage of drinking days (TLFB) • Drinks per drinking day (TLFB) • Asking participants how much money they spent on personal consumption | • Self-reported ARV adherence • HIV RNA concentration (<40 copies/ml) | • Significantly lower percentage of drinking days and drinks per drinking day in CBT than HL overall and at all study phases • Adherence and competence scores in both CBT and HL conditions did not differ significantly by gender |
Wechsberg et al., 2019 [27] | N=641 Black African women (aged 15 or older) in 14 communities who reported weekly use of at least one substance, which could be alcohol; subanalyses conducted with N=317 women living with HIV who reported using alcohol; South Africa | Intervention: Women’s Health CoOp Plus (WHC+) and standard HIV counseling and testing; 2-h-long individual sessions with personalized action plan Standard HIV Counseling and Testing | • Average number of drinks per day | • Undetectable viral load (<1360 copies/ml) for subsample | • Among the subsample with viral load data, the WHC+ arm was statistically significantly more likely to have a nondetectable viral load (p=0.01) at 12-month follow-up; this difference was not statistically significant at 6-month follow-up • Women in the WHC+ arm reported significantly fewer drinks per day and days of drinking in the past month than participants in the comparison condition |
Wechsberg et al., 2021 [69] | N=480 Women living with HIV (aged 18 to 45) who report the use of at least one drug at least weekly in the past 3 months (one of which could be alcohol); South Africa | Intervention: Women’s Health CoOp (WHC): 2-session empowerment-based group workshop addressing HIV, STIs, TB, condoms, sexual risk reduction, alcohol and other drugs, violence, and negotiation skills WHC implemented in health and substance use clinics over 4-cycles via a modified stepped- wedge design implementation science trial | • Alcohol use (self-reported frequency, amount, binge drinking to calculate heavy alcohol use [4 or more drinks on any given day, and 7 or more drinks per week]) | • ART initiation and adherence • Awareness of CD4 count | • Compared with cycle 1, women in cycle 4 were significantly less likely to AUD risk at 6-month follow-up • Compared with women in cycle 1, women in cycle 4 were significantly more likely to report taking ART in the past 6 months at follow-up • Likelihood of taking ART increases as women are enrolled in the later cycles and the risk of AUD decreases • WHC increased ART adherence and reduced alcohol use |
Protocols for Ongoing Gender-Focused Studies
Citation | Planned population/setting | Study arms | Proposed alcohol outcomes | Proposed HIV and viral load outcomes | Proposed findings gender-focused |
---|---|---|---|---|---|
DiClemente et al., 2021 [71] | N=200 Adult women living with confirmed HIV/HCV coinfection aged 18 to 45 who currently use alcohol and who are selected from HIV care clinics; Russia | Intervention: Standard of Care + Brief computerized intervention addressing relevant health topics concluding with individual visits with study clinicians to set alcohol consumption goals Standard of Care: Women are routinely asked about their alcohol consumption and referred to treatment facilities if necessary; health educational brochure relevant to HIV/HCV and alcohol | • PEth levels (8 ng/ml) • EtG levels (500 ng/ml) | • HIV viral load (copies/ml) • CD4+ cell count | • To determine if a computer-based intervention that could provide better patient confidentiality and increased accessibility is efficacious in improving alcohol and HIV/HCV outcomes |
Kane et al., 2020 [72] | N=180 People living with HIV with high-risk alcohol use and potential mental health or other substance use comorbidities from two hospitals with large HIV clinics; Zambia | Intervention: CETA adapted for HIV clinical settings; CBT for substance use reduction; IND; 6 to 12 1-h sessions Intervention: Alcohol Behavioral Intervention adapted from CETA elements for Substance Use Reduction | • 10-item AUDIT • ASSIST substance use measurement | • No proposed adherence or viral load outcomes | • Will reveal the effectiveness of an intervention addressing substance use and other comorbidities in an HIV clinic setting in sub-Saharan Africa |
Magidson et al., 2020 [73] | N=60 Adults living with HIV who are currently on ART but struggling with adherence and with moderate substance use from an HIV clinic in Khayelitsha; South Africa | Hybrid Type 1 effectiveness implementation trial Intervention: LifeSteps + Motivational Interviewing; Relapse prevention skills; 6 sessions lasting between 45 min and 1 h Standard of Care: Referral to substance use treatment services | • Urinalysis and self-report • WHO ASSIST | • ART adherence measured through Wisepill • Viral load (copies/ml) | • Determine whether this evidence-based intervention can be integrated into HIV care settings, considering workforce shortage in South Africa • Establish whether this intervention successfully addresses both HIV treatment and substance use |