Table 2.

Summary of Clinical and Implementation Trials for Behavioral Health Conditions in Persons with HIV

Author (Year)	Sex, Age, country	Design, number of participants, and length of cessation intervention	Smoking Cessation Intervention	Outcome	Measure of effect	Effect estimate (95% CI)
Randomized Clinical Trials for Smoking Cessation
Kim et al. (2018)	Female 100% Mean age (SD), years: 51 (7.7) United States	Parallel RCT Video vs voice call interventions (N=42, n=21 per arm) Two-block randomization Both arms received an HIV-tailored smoking cessation intervention	1) Video-call+NRT 2) Voice-call +NRT	6-month prolonged abstinence	Odds ratio	Video-call vs voice-call 10.0 (1.1, 90.6)
Mercie et al. (2018)	Male 83% Mean age (SD), years: 45 (9) France	Parallel RCT Varenicline (N=123) vs placebo (N=124) Randomization stratified by smoking counselor type (ID specialist or tobacco treatment specialist) and by center had participation in an ancillary study on lung aging. First treatment 12-weeks Weeks 13-24 no treatment; Second treatment in Weeks 25 – 37 for those who resumed smoking	1) Varenicline + smoking cessation counseling 2) Placebo + smoking cessation counseling	Biologically confirmed Continuous abstinence from weeks 9 to 48 Continuous abstinence from weeks 9 to 12	Odds Ratio	2.5 (1.0, 6.1) 3.2 (1.6, 6.4)
O’Cleirigh et al. (2018)	Male 75% Mean age (SD), years: 50.5 (8.2) United States	Parallel RCT Block randomization in blocks of 4 Both arms received a 60-minute psychoeducation session before randomization (session 1). Both groups were provided NRT at week 6 (quit date) Total N = 53 QUIT – nine 60-minutes sessions + NRT (N=26) ETAU – 4 10-minutes sessions + NRT (N=27)	1) QUIT – (CBT + NRT) ETAU – Corresponding to weeks 7-10 of QUIT intervention, control condition received 4 post-quit 10-minute sessions	7-day point-prevalence abstinence Anxiety and depressive symptoms	Beta	At end of treatment 5.60 (2.64, 8.56) At 6-months 7.69 (4.6, 10.8) At end of treatment 0.46 (0.09, 0.84) At 6-months 0.37 (0.05, 0.69)
Implementation Trial for Smoking Cessation
Cropsey et al (2019)	United States	Single-arm pilot study Integration of smoking cessation decision algorithm within routine clinic visits to engage non-treatment-seeking smokers in smoking cessation therapies	Pre-post – baseline to follow-up smoking behavior	Self-reported smoking behavior (cigarettes per day) Nicotine dependence (Fagerstrom Test for Nicotine Dependence score)	Average frequencies	Baseline vs 3-month follow-up 14.4 vs. 7.1 cigarettes per day 5.6 vs 3.6 nicotine dependence
Randomized Clinical Trials for Unhealthy Alcohol Use
Edelman (2019)	98% male Mean age, years: 54 (range 23-70 years) United States	N randomized=128 n = 63 intervention n = 65 usual care 24-week treatment; 52-week study Jan 2013-July 2017	Stepped alcohol treatment with intensification at pre-defined intervals integrated into HIV care.	Primary: Drinks per week over the past 30-days at week 24	Adjusted mean difference	No difference by treatment group: 10.4 (SD=16.5) vs. 15.6 (SD=17.6) Adjusted mean difference −4.2 [−9.4, 0.9; p=0.11] drinks per week in the past 30 days
Edelman (2019)	71% male; Recently released inmates Mean age (SD), years: 51 (8) United States	N randomized=51 n = 25 intervention drug PLUS counseling n = 26 placebo PLUS counseling 24-week treatment April 2011-February 2015	Extended release naltrexone plus counselling	Primary: ≥95% ART adherence;	Adjusted mean difference in proportion	34% vs 23% with ≥95% ART adherence (p=0.4) in naltrexone vs. control group.
Edelman (2019)	99% male Mean age, years: 61 (range 33-87) United States	N randomized=95 n = 49 intervention n = 46 control 24-week treatment; 52-week study January 2013-July 2016	Stepped alcohol treatment with intensification at pre-defined intervals integrated into HIV care.	Primary: past 30-day alcohol abstinence at week 24	Adjusted odds ratio	No difference in self-reported abstinence at 24 weeks (38% vs 23%; AOR 2.6 [0.8, 9.0] p=0.12. All participants increased abstinence over time.
Springer (2018) Springer (2017)	77% male Mean age (SD), years: 45 (8) United States	N randomized=100 n = 67 intervention drug n = 33 placebo 6-month treatment September 2010-February 2016	Extended release naltrexone	Primary (2018): achieve-maintaining HIV viral suppression; Primary (2017): time to first heavy drinking day; number of drinks/drinking day; percent heavy drinking days; pre vs. post incarceration change in average drinks/drinking day; total number of drinking days	Difference in proportion	Extended release naltrexone associated with improved viral suppression (48 to 64%; p=0.02) from baseline to 6 months vs placebo (64 to 42%; p=0.07) Limited differences by treatment group in alcohol consumption; younger (20-29 years) had longer time to first heavy drinking day in naltrexone vs. placebo arm (24 vs 9.5 days p;<0.001)
Kahler (2018)	100% men who have sex with men Mean age (SD), years: 42 (10) United States	N randomized=180 n = 89 intervention n = 91 control 6-month intervention; 12-month study December 2011-March 2016	60-min, in-person motivational interviewing session with personalized feedback + two brief phone sessions and in-person booster sessions of 10–20 min each at the 3- and 6-month follow-up visits.	Primary: Average number of drinks per week; number of heavy drinking days in the past 30 days	Adjusted Beta (95% CI)	Decline in drinks per week faster in intervention group (50% by 6 months vs. 25% reduction by 12 months). Intervention group had 8.72 fewer drinks at 6 months and 5.98 fewer drinks at 12 months vs control group. Intervention group had fewer heavy drinking days at 6 months (45% lower) and less heavy drinking at 12 months (62% vs. 78%)
Cook (2019)	100% women Mean age (SD), years: 48 (9) United States	N randomized=194 n = 96 intervention n = 98 placebo control 4-month intervention; 7-month study 2013-2016	Naltrexone	Primary: quit drinking or reduction below unhealthy levels (≤7 drinks/week or ≤3 drinks/day in past 30 days)	Odds ratio	No significant difference in odds of reducing/quitting drinking: 1.32 (0.73-2.41; p=0.36). No significant difference between groups on other alcohol outcomes though both groups reduced consumption
Huis in ‘t Veld (2019)	54% men Medan age, years: 36 years (IQR=31-42) South Africa	N randomized = 560 n = 267 intervention n = 293 control 1-day intervention; 12-month study	Single delivery of WHO brief intervention package; personalized feedback on AUDIT results; health education leaflet on responsible drinking; advice and brief counseling on excessive drinking	Primary: (from 3 to 12 months) reduction in AUDIT score from hazardous/harmful to abstinence or low risk use	Odds ratio	No difference by intervention status for primary outcome or secondary AUDIT score outcomes (estimates not provided)
Emenyonu (2017)	55% men Median age, years: 30 years (IQR=25-36) Uganda	N randomized= 373 n = 207 intervention n = 166 control	Quarterly alcohol use and HIV assessments (vs. single, limited assessment at 6 months after initial baseline assessment)	AUDIT-C≥3 (men) ≥4 (women) or PEth≥50ng/ml at 6 months	Odds ratio	No difference in unhealthy alcohol consumption at 6 months aOR:0.95 (0.60, 1.51)
Wandera (2019)	66% men Median age, years: 39 years (IQR=32-46) Uganda	N randomized =337 n = 167 intervention n = 170 control 20-30 minute intervention; 6-month study	Single delivery of brief alcohol counseling (motivational interviewing) plus “positive prevention” information	Primary: mean AUDIT-C score	Mean AUDIT-C change	No differential AUDIT-C reduction by study arm. Mean AUDIT-C change at 6 months = 0.01 (−0.32, 0.34)
Randomized Clinical Trials for Opioid Use Disorder
Author (Year)	Sex, Age, country	Design, number of participants, and length of cessation intervention	Intervention	Outcome	Measure of effect	Effect estimate (95% CI)
Korthuis (2017)	43% Female Mean age (SD), years:) 46 (10) United States	Open-label, randomized, pilot trial	extended-release naltrexone (XR-NTX) vs treatment as usual (TAU)	Opioid use	Mean difference from baseline to 16-week follow-up	TAU vs XR-NTX Mean days in past month Baseline 17.3 vs 20.3 Follow-up 4.1 vs. 7.7 UDS positive for opioids Baseline 9% vs 9% Follow-up 7% vs 4%