Scaling up a brief alcohol intervention to prevent HIV infection in Vietnam: a cluster randomized, implementation trial.

BACKGROUND: Evidence-based interventions (EBIs) often address normative behaviors. If a behavior is also common among clinicians, they may be skeptical about the necessity or effectiveness of an EBI. Alternatively, clinicians' attitudes and behaviors may be misaligned, or they may lack the knowledge and self-efficacy to deliver the EBI. Several EBIs address unhealthy alcohol use, a common and often culturally acceptable behavior. But unhealthy alcohol use may be particularly harmful to people with HIV (PWH). Here, we present an implementation trial using an experiential implementation strategy to address clinicians' knowledge, attitudes, and behaviors. Clinicians receive the experiential intervention before they begin delivering an evidence-based brief alcohol intervention (BAI) to PWH with unhealthy alcohol use. METHODS: Design: In this hybrid type 3 implementation-effectiveness cluster randomized controlled trial, ART clinics (n = 30) will be randomized 1:1 to facilitation, a flexible strategy to address implementation barriers, or facilitation plus the experiential brief alcohol intervention (EBAI). In the EBAI arm, clinicians, irrespective of their alcohol use, will be offered the BAI as experiential learning. EBAI will address clinicians' alcohol-related attitudes and behaviors and increase their knowledge and confidence to deliver the BAI. PARTICIPANTS: ART clinic staff will be enrolled and assessed at pre-BAI training, post-BAI training, 3, 12, and 24 months. All PWH at the ART clinics who screen positive for unhealthy alcohol use will be offered the BAI. A subset of PWH (n = 810) will be enrolled and assessed at baseline, 3, and 12 months. OUTCOMES: We will compare implementation outcomes (acceptability, fidelity, penetration, costs, and sustainability) and effectiveness outcomes (viral suppression and alcohol use) between the two arms. We will assess the impact of site-level characteristics on scaling-up the BAI. We will also evaluate how experiencing the BAI affected clinical staff's alcohol use and clinic-level alcohol expectations in the EBAI arm. DISCUSSION: This trial contributes to implementation science by testing a novel strategy to implement a behavior change intervention in a setting in which clinicians themselves may engage in the behavior. Experiential learning may be useful to address normative and difficult to change lifestyle behaviors that contribute to chronic diseases. TRIAL REGISTRATION: NCT06358885 (04/10/2024), https://clinicaltrials.gov/study/NCT06358885 .

Efficacy of Two Evidence-Based Alcohol Consumption Interventions on Positive, Negative, and Neutral Days Among Hazardous Alcohol Users Living with HIV in Vietnam.

Social events and stressful settings can be catalysts for alcohol consumption. Motivational enhancement therapy (MET) and cognitive behavioral therapy (CBT) are widely used in alcohol interventions. We assessed how alcohol consumption varied across three types of days (positive/social, negative/stressful, and neutral) among hazardous alcohol users living with HIV in Vietnam. We further evaluated how those consumption patterns changed after two MET/CBT alcohol reduction interventions versus the standard of care (SOC). The 'combined' intervention offered 6 individual sessions and 3 group sessions; the 'brief' intervention offered 2 individual sessions and 2 phone calls. A 30-day timeline follow-back was administered at study visits, detailing daily drinks and events. Days were categorized as neutral, positive/social, or negative/stressful; negative binomial models and generalized estimating equations were used to estimate drinks consumed by type of day at baseline and 12 months. Prior to intervention, more drinks were consumed on positive/social days (5.2 drinks; 95% Confidence Interval [CI]:4.8, 5.7) than negative/stressful (1.5; 95% CI:1.3, 1.9) and neutral days (2.2; 95% CI: 1.9, 2.5). After the brief intervention, drinks consumed decreased on neutral days (ratio: 0.5: 95% CI: 0.4, 0.7). After the combined intervention, drinks consumed decreased on neutral days (ratio: 0.4; 95% CI: 0.3, 0.6), positive/social days (ratio: 0.6; 95% CI: 0.5, 0.7) and negative/stressful days (ratio: 0.3; 95% CI: 0.2, 0.6). No reductions in consumption were observed in the SOC group. Social/positive days had the highest alcohol consumption prior to intervention, and the combined intervention showed the greatest decrease in consumption on those days. CLINICAL TRIAL REGISTRATION: The study is registered at clinicaltrials.gov (NCT02720237).

Validation of the combined Patient Health Questionnaire Anxiety and Depression Scale among people with HIV in Vietnam.

BACKGROUND: Our study aims to examine the factor structure, validity, and reliability of the combined scale Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) among people with HIV (PWH) in Vietnam. METHODS: Baseline data from an alcohol-reduction intervention trial among ART clients in Thai Nguyen, Vietnam were used for this analysis (n = 1547). A score ≥10 on the PHQ-9, GAD-7 and PHQ-ADS scale was considered having clinically meaningful depression, anxiety and distress symptoms. Factor structure of the combined PHQ-ADS scale was validated using confirmatory factor analysis, and three models were tested: a one-factor, a two-factor, and a bi-factor model. Reliability and construct validity were examined. RESULTS: The prevalence of clinically meaningful depression and anxiety symptoms was 7% and 2%, respectively, while 19% had distress symptoms. A bi-factor model had the best fit to the data (RMSEA = 0.048; CFI = 0.99; TLI = 0.98). The Omega index of the bi-factor model was 0.97. The scale showed good construct validity through negative associations between depression, anxiety, distress symptoms and quality of life. CONCLUSIONS: Our study supports the use of a combined scale to measure general distress for PWH, which has good validity, reliability and is unidimensional enough to justify the use of a composite depression and anxiety score.

Phosphatidylethanol and self-reported alcohol consumption among people living with HIV in Thai Nguyen, Vietnam.

BACKGROUND: Phosphatidylethanol (PEth) is a biomarker for recent alcohol consumption that would ideally validate self-reported alcohol consumption behaviors. We assessed the relationship between PEth and several self-reported alcohol consumption metrics among hazardous alcohol users living with HIV in Vietnam. METHODS: Participants in a three-arm randomized controlled trial assessing two alcohol interventions reported recent alcohol consumption on a 30-day timeline follow-back interview and had a PEth assessment at enrollment, 3 months, and 12 months of the study follow-up. We examined the relationship between self-reported alcohol consumption and quantitative PEth results using Spearman rank correlation and receiver-operating characteristic (ROC) curves to calculate the area under the curve (AUC). We assessed associations between categorical PEth results and self-reported drinking behaviors using prevalence ratios calculated with regression models and generalized estimating equations. RESULTS: Among 1221 study visits (n = 439 participants; 425 (97%) men), the median PEth result was 71 ng/mL (Interquartile range (IQR): 20, 212), and participants reported a median of 11 (IQR: 4, 24) drinking days and 25 (IQR: 8, 71) standard drinks in the previous 28 days. Quantitative PEth results were moderately correlated with drinking days (ρ = 0.26-0.35) and standard drinks consumed (ρ = 0.23-0.38) in the same period. AUCs ranged from 0.54 (any binge drinking in the past 28 days) to 0.82 (any alcohol consumed in the past 21 days). Positive PEth results (≥50 ng/mL) were 2.24 (95% Confidence Interval [CI]: 1.49, 3.35) times as prevalent among participants who reported drinking in the previous 28 days compared with those who did not. CONCLUSIONS: Although PEth values and self-reported alcohol use were correlated, the observed associations were modest. Additional research into the dynamics of PEth production and elimination is warranted across diverse populations to better understand how PEth assessments can best be integrated into research and clinical care.

Acceptability and feasibility of long-acting injectable antiretroviral therapy for HIV-infected persons who inject drugs in Vietnam: A qualitative study.

Background: In Vietnam, HIV prevalence among people who inject drugs (PWID) is several times higher than in the general population (15% versus 0.3%). PWID also experience higher rates of HIV-related mortality, driven by poor antiretroviral therapy (ART) adherence. Long-acting injectable ART (LAI) is a compelling opportunity to improve treatment outcomes, but acceptability and feasibility among HIV-infected PWID remains unexplored. Methods: We conducted key informant in-depth interviews in Hanoi, Vietnam (February-November 2021). Participants were purposively sampled and included policymakers, ART clinic staff, and HIV-infected PWID. We applied the Consolidated Framework for Implementation Research to guide study design and analysis, using thematic coding to develop and iteratively refine a codebook and characterize barriers and facilitators to LAI implementation. Findings: We interviewed 38 key stakeholders: 19 PWID, 14 ART clinic staff, and five policymakers. Participants were enthusiastic about LAI convenience, highlighting less frequent and more discreet dosing. However, contrasting providers, several policymakers suggested LAI was not needed given perceived exceptional oral ART outcomes and rare viral failure among PWID. Policymakers also criticized strategies prioritizing PWID for LAI, emphasizing equity, whereas providers identified PWID as an ideal population for LAI given adherence challenges. LAI complexity, including storage and administration logistics, were deemed surmountable with training and resources. Finally, providers and policymakers acknowledged that adding LAI to drug formularies was key, but an onerous process. Interpretation: Although anticipated to be resource-intensive, LAI was a welcome addition for interviewed stakeholders and likely an acceptable alternative to oral ART among PWID living with HIV in Vietnam. Despite enthusiasm among PWID and providers that LAI could improve viral outcomes, some policymakers-whose buy-in is critical to LAI implementation-opposed strategies that preferentially distributed LAI to PWID, highlighting values of equity and revealing differences in perceived HIV outcomes among PWID. Results provide a vital foundation for developing LAI implementation strategies. Funding: Supported by National Institutes of Health.

Longitudinal Trajectories of Alcohol Use in Vietnamese Adults with Hazardous Alcohol Use and HIV.

A three-armed drinking cessation trial in Vietnam found that both a brief and intensive version of an intervention effectively reduced hazardous drinking in people living with HIV. We used group-based trajectory modeling (GBTM) to assess the extent to which findings may vary by latent subgroups distinguished by their unique responses to the intervention. Using data on drinking patterns collected over the 12 months, GBTM identified five trajectory groups, three of which were suboptimal ["non-response" (17.2%); "non-sustained response" (15.7%), "slow response" (13.1%)] and two optimal ["abstinent" (36.4%); "fast response" (17.6%)]. Multinomial logistic regression was used to determine that those randomized to any intervention arm were less likely to be in a suboptimal trajectory group, even more so if randomized to the brief (vs. intensive) intervention. Older age and higher baseline coping skills protected against membership in suboptimal trajectory groups; higher scores for readiness to quit drinking were predictive of it. GBTM revealed substantial heterogeneity in participants' response to a cessation intervention and may help identify subgroups who may benefit from more specialized services within the context of the larger intervention.

The role of depression in secondary HIV transmission among people who inject drugs in Vietnam: A mathematical modeling analysis.

BACKGROUND: Among people who inject drugs (PWID), depression burden is high and may interfere with HIV prevention efforts. Although depression is known to affect injecting behaviors and HIV treatment, its overall impact on HIV transmission has not been quantified. Using mathematical modeling, we sought to estimate secondary HIV transmissions and identify differences by depression among PWID. METHODS: We analyzed longitudinal data from 455 PWID living with HIV in Vietnam during 2009-2013. Using a Bernoulli process model with individual-level viral load and behavioral data from baseline and 6-month follow-up visits, we estimated secondary HIV transmission events from participants to their potentially susceptible injecting partners. To evaluate differences by depression, we compared modeled transmissions per 1,000 PWID across depressive symptom categories (severe, mild, or no symptoms) in the three months before each visit. RESULTS: We estimated a median of 41.2 (2.5th, 97.5th percentiles: 33.2-49.2) secondary transmissions from all reported acts of sharing injection equipment with 833 injecting partners in the three months before baseline. Nearly half (41%) of modeled transmissions arose from fewer than 5% of participants in that period. Modeled transmissions per 1,000 PWID in that period were highest for severe depressive symptoms (100.4, 80.6-120.2) vs. mild (87.0, 68.2-109.4) or no symptoms (78.9, 63.4-94.1). Transmission estimates fell to near-zero at the 6-month visit. CONCLUSIONS: Secondary transmissions were predicted to increase with depression severity, although most arose from a small number of participants. Our findings suggest that effective depression interventions could have the important added benefit of reducing HIV transmission among PWID.

HIV and STI prevalence and testing history among men who have sex with men in Hanoi, Vietnam.

BACKGROUND: HIV and other sexually transmitted infections (STIs) have disproportionately affected communities of men who have sex with men (MSM). We describe HIV and STI prevalence and testing patterns among urban Vietnamese MSM. METHODS: We conducted a cross-sectional community-based study of MSM in Hanoi, Vietnam in 2016. Participants self-reported experiences of social stigma in healthcare settings and previous HIV and STI testing. STI testing included HIV, herpes simplex virus-2 (HSV-2), syphilis, gonorrhea, and chlamydia. RESULTS: 205 MSM participated in the study. STI prevalence was HIV (10%), HSV-2 (4%), syphilis (13%), gonorrhea (34%), and chlamydia (19%). More than half (55%) of participants tested positive for at least one STI. Most participants had been previously tested for HIV or another STI (72%), with 24% previously receiving a positive result. Perceived and enacted social stigma in healthcare contexts was negatively associated with previous HIV or STI testing (adjusted prevalence odds ratio (aPOR): 0.22; 95% confidence interval (CI): 0.10-0.48). DISCUSSION: High prevalence of STIs was observed among Vietnamese MSM, and perceived and enacted stigma was related to HIV and STI testing. Our findings reaffirm the importance of regular STI screening among this population as well as additional outreach to promote safe HIV and STI healthcare engagement.

Association between drug use and ART use among people living with HIV who inject drugs in Vietnam, Ukraine and Indonesia: results from HPTN 074.

Background and objective: Drug use type and frequency may affect Anti-Retroviral Therapy (ART) uptake for HIV-infected people who inject drugs (PWID). This paper assesses the association between self-reported baseline drug use and ART among HIV-infected PWID in Indonesia, Ukraine and Vietnam. Methods: Data on self-reported baseline drug use and ART among HIV-infected PWID at the 26- and 52-week follow-ups were extracted from the HIV Prevention Trials Network (HPTN) 074, a randomized, controlled vanguard study to facilitate HIV treatment for PWID in Indonesia, Ukraine, and Vietnam. Multivariable logistic regression models were fit by study site and the whole HPTN 074 sample, using a 0.5 type I error rate. Results: The response rate were 83.3% and 77.0% at 26th and 52th weeks. At 26-week, baseline use of over one non-opiate/non-stimulant drug was associated with lower odds of ART use among Indonesian participants (OR = 0.21, 95%CI: 0.05-0.82); and baseline injecting drugs for over 20 days in the previous month was associated with lower odds of ART use among all HPTN 074 sample (OR = 0.59, 95% CI: 0.36-0.97). Conclusion: The association of a specific drug use pattern with later ART uptake implies the importance of medication-assisted treatment to enhance ART uptake and adherence among participants.

The longitudinal association between depression, anxiety symptoms and HIV outcomes, and the modifying effect of alcohol dependence among ART clients with hazardous alcohol use in Vietnam.

INTRODUCTION: Mental health disorders may negatively impact HIV outcomes, such as viral suppression (VS) and antiretroviral (ART) adherence among people with HIV (PWH) with hazardous alcohol use. This study evaluates the longitudinal association between depression, anxiety symptoms, VS and complete ART adherence among ART clients with hazardous alcohol use in Vietnam; and examines alcohol dependence as a modifier in this association. METHODS: This was a secondary data analysis of a trial for hazardous drinking ART clients in Thai Nguyen, Vietnam. From March 2016 to May 2018, 440 ART clients with an Alcohol Use Disorders Identification Test-Concise (AUDIT-C) score ≥4 for men and ≥3 for women were enrolled. Individuals were randomized to either a combined intervention, a brief intervention or a standard of care. Data on sociodemographics, depression, anxiety symptoms, alcohol use, VS and ART adherence were collected at baseline, three, six, and twelve months. Generalized estimating equation models controlling for intervention exposure were used to estimate time-lagged associations. Risk ratios were estimated using Poisson regression with robust variance estimation. RESULTS: The mean age of participants was 40.2. The majority was male (96.8%), had at least some secondary school education (85.0%) and had a history of injection drug use (80.9%). No overall effect of depression and anxiety symptoms on VS was observed. When stratified by time, increased anxiety symptoms at six months were associated with VS at 12 months (adjusted risk ratio (aRR) = 1.09; 95% CI 1.02 to 1.17). An increase in depression or anxiety symptoms was associated with a decreased probability of complete ART adherence (depression symptoms: aRR = 0.95; 95% CI: 0.91 to 0.99; anxiety symptoms: aRR = 0.93; 85% CI: 0.88 to 0.99). The negative effects of anxiety symptoms on ART adherence were stronger among participants with alcohol dependence, compared to those without. CONCLUSIONS: Depression and anxiety symptoms had no overall effect on VS, although they were associated with a lower probability of complete ART adherence. Interventions focusing on mental healthcare for PWH with hazardous alcohol use are needed, and integration of mental healthcare and alcohol reduction should be implemented in HIV primary care settings.

Evaluating the effects of two alcohol reduction counseling interventions on intimate partner violence perpetration: secondary analysis of a three-arm randomized controlled trial among Vietnamese men with HIV.

BACKGROUND AND AIMS: Evidence suggests that alcohol reduction interventions decrease intimate partner violence (IPV) perpetration, although this remains untested in low- and middle-income countries and among men with human immunodeficiency virus (HIV). This study evaluates the effectiveness of alcohol reduction counseling interventions on IPV perpetration among men on anti-retroviral therapy (ART) and tests whether alcohol use explains the intervention effects. DESIGN: Secondary analysis of data from a three-arm randomized controlled trial among ART patients with hazardous alcohol use. Participants were recruited from March 2016 to May 2017. SETTING: Thai Nguyen, Vietnam. PARTICIPANTS, INTERVENTIONS AND COMPARATORS: Male participants (n = 426). Participants received a two-session brief intervention (BI), a six-session combined intervention (CoI) or the standard of care (SOC), comprising alcohol treatment referrals. Alcohol reduction counseling interventions were guided by cognitive-behavioral therapy and motivational enhancement therapy delivered by psychosocial counselors over 3 months. MEASUREMENTS: IPV perpetration was measured using the shortened Conflict Tactics Scale 2 and alcohol use was measured using timeline followback. FINDINGS: BI and CoI participants reported reduced IPV perpetration at 3 months compared with SOC participants [BI: adjusted odds ratio (aOR) = 0.27, 95% confidence interval (CI) = 0.11, 0.65; CoI: aOR = 0.50, 95% CI = 0.22, 1.13]; the association was only significant for the BI group. Intervention effects were not sustained at 6 and 12 months. There was little evidence that alcohol use acted as a mediator (indirect effect, BI: aOR = 0.84, 95% CI = 0.63, 1.04; indirect effect, CoI: aOR = 0.86, 95% CI = 0.66, 1.03). CONCLUSIONS: Among Vietnamese men receiving anti-retroviral therapy, alcohol reduction counseling interventions appeared to reduce intimate partner violence perpetration immediately post-intervention, but reductions were not sustained at 6 and 12 months and were not explained by alcohol reduction.

The Cost-Effectiveness of Adapting and Implementing a Brief Intervention to Target Frequent Alcohol Use Among Persons with HIV in Vietnam.

Brief interventions to reduce frequent alcohol use among persons with HIV (PWH) are evidence-based, but resource-constrained settings must contend with competition for health resources. We evaluated the cost-effectiveness of two intervention arms compared to the standard of care (SOC) in a three-arm randomized control trial targeting frequent alcohol use in PWH through increasing the percent days abstinent from alcohol and viral suppression. We estimated incremental cost per quality-adjusted life year (QALY) gained from a modified societal perspective and a 1-year time horizon using a Markov model of health outcomes. The two-session brief intervention (BI), relative to the six-session combined intervention (CoI), was more effective and less costly; the estimated incremental cost-effectiveness of the BI relative to the SOC, was $525 per QALY gained. The BI may be cost-effective for the HIV treatment setting; the health utility gained from viral suppression requires further exploration.

Depression, antiretroviral therapy initiation, and HIV viral suppression among people who inject drugs in Vietnam.

BACKGROUND: The burden of depression is high among people who inject drugs (PWID) and may contribute to the spread of HIV through poor treatment engagement and persistent viremia. We estimated the effects of depression on antiretroviral therapy (ART) initiation and viral suppression among PWID living with HIV. METHODS: Longitudinal data were collected from 455 PWID living with HIV in Vietnam during 2009-2013. We estimated the 6- and 12-month cumulative incidence of ART initiation and viral suppression, accounting for time-varying confounding, competing events, and missing data. The cumulative incidence difference (CID) contrasted the incidence of each outcome had participants always vs. never experienced severe depressive symptoms across study visits to date. RESULTS: Severe depressive symptoms decreased the cumulative incidence of ART initiation, with CID values comparing always vs. never having severe depressive symptoms of -7.5 percentage points (95% CI: -17.2, 2.2) at 6 months and -7.1 (95% CI: -17.9, 3.7) at 12 months. There was no appreciable difference in the cumulative incidence of viral suppression at 6 months (CID = 0.3, 95% CI: -11.3, 11.9) or 12 months (CID = 2.0, 95% CI: -21.8, 25.8). LIMITATIONS: Discrepancies between the ART initiation and viral suppression outcomes could be due to under-reporting of ART use and missing data on viral load. CONCLUSIONS: Future work probing the seemingly antagonistic effect of depression on treatment uptake - but not viral suppression - will inform the design of interventions promoting HIV clinical outcomes and reducing onward transmission among PWID.

Minority Stress and Experience of Sexual Violence Among Men Who Have Sex With Men in Hanoi, Vietnam: Results From a Cross-Sectional Study.

Men who have sex with men (MSM) are highly vulnerable to sexual violence, a known driver of HIV infection. Homosexuality stigma may be a unique risk factor for sexual violence among MSM. In this study, we examine the relationship between homosexuality stigma measures and sexual violence in the last 12 months using a minority stress framework. MSM were recruited using convenience and snowball sampling. Participants completed an interviewer-administered survey and provided blood samples for HIV testing. Bivariable associations were tested between self-reported experience of sexual violence in the last 12 months and homosexuality stigma measures using odds ratios (ORs) produced by Cochran-Mantel-Haenszel Statistics. A logistic regression model for each type of minority stress was built to conduct the multivariable analyses with independent covariates. Of 202 MSM, 29 (14.4%) participants reported experiencing sexual violence in the last 12 months. About one fourth of participants reported experiencing high enacted (55/202; 27.2%), perceived (52/202; 25.7%), and internalized (60/202; 29.7%) homosexuality stigma. In bivariable and multivariable analyses, enacted homosexuality stigma was the only variable consistently associated with experience of sexual violence in the last 12 months (aOR: 3.5; 95% confidence interval [CI]: [1.5, 8.4]). Sexual violence and homosexuality stigma are highly prevalent among MSM in Hanoi, Vietnam. MSM-targeted HIV prevention interventions in Vietnam should incorporate violence prevention and homosexuality stigma reduction activities. Longitudinal studies are needed to understand how homosexuality stigma influences sexual violence and other HIV risk behaviors among MSM.

Estimating the Effect of Depression on HIV Transmission Risk Behaviors Among People Who Inject Drugs in Vietnam: A Causal Approach.

The burden of depression and HIV is high among people who inject drugs (PWID), yet the effect of depression on transmission risk behaviors is not well understood in this population. Using causal inference methods, we analyzed data from 455 PWID living with HIV in Vietnam 2009-2013. Study visits every 6 months over 2 years measured depressive symptoms in the past week and injecting and sexual behaviors in the prior 3 months. Severe depressive symptoms (vs. mild/no symptoms) increased injection equipment sharing (risk difference [RD] = 3.9 percentage points, 95% CI -1.7, 9.6) but not condomless sex (RD = -1.8, 95% CI -6.4, 2.8) as reported 6 months later. The cross-sectional association with injection equipment sharing at the same visit (RD = 6.2, 95% CI 1.4, 11.0) was stronger than the longitudinal effect. Interventions on depression among PWID may decrease sharing of injection equipment and the corresponding risk of HIV transmission.Clinical trial registration ClinicalTrials.gov NCT01689545.

Alcohol use, depressive symptoms, and intimate partner violence perpetration: A longitudinal analysis among men with HIV in northern Vietnam.

BACKGROUND: While the link between alcohol use and male-perpetrated intimate partner violence (IPV) has been well-established, research is needed to test whether psychosocial factors interact with alcohol use to exacerbate IPV perpetration. We tested whether depressive symptoms influenced the strength and/or direction of the alcohol-IPV relationship among men with HIV in Vietnam. METHODS: This study is a secondary analysis using data from a randomized controlled trial conducted in Thai Nguyen, Vietnam. Participants were clinic patients with HIV and hazardous alcohol use. Questionnaires were administered at baseline, three, six, and 12 months. Alcohol use was assessed as proportion of days alcohol abstinent. Analyses were restricted to males who reported being married/cohabitating at baseline (N = 313). Multilevel growth models were used to test whether time-varying depressive symptoms modified the time-varying effect of alcohol use on IPV perpetration. RESULTS: Time-varying depressive symptoms modified the effect of proportion of days alcohol abstinent on IPV perpetration. However, the pattern of effect modification was not as expected, as reporting depressive symptoms weakened the alcohol-IPV relationship. At times when participants screened negative for depressive symptoms, those who reported higher proportion of days alcohol abstinent than usual had significantly lower odds of IPV perpetration (Odds Ratio [OR] = 0.17, 95% Confidence Interval 0.06, 0.45, p = 0.0004). At times when participants screened positive for depressive symptoms, there was no observed effect of alcohol use on IPV perpetration (OR = 4.28, 95% CI 0.80, 22.78, p = 0.09). CONCLUSION: The findings highlight the complex nature of the alcohol-IPV relationship and the need to investigate the intersection between hazardous drinking, mental health, and IPV. Men who concurrently report depressive symptoms and heightened alcohol use may be socially isolated from an intimate partner or experiencing fatigue, leading to less alcohol-related IPV perpetration. Mental health interventions addressing depression and alcohol misuse integrated into HIV services may reduce IPV perpetration.

Alcohol abstinence stigma and alcohol use among HIV patients in Thai Nguyen, Vietnam.

BACKGROUND: Hazardous alcohol use is prevalent among people living with HIV (PWH), leading to sub-optimal HIV treatment outcomes. In Vietnam, alcohol use is highly normative making it socially challenging for PWH to reduce or abstain. We used mixed methods to develop a quantitative scale to assess alcohol abstinence stigma and examined the association between alcohol abstinence stigma with alcohol use among PWH in Vietnam. METHODS: We conducted qualitative interviews with 30 PWH with hazardous alcohol use from an antiretroviral therapy (ART) clinic in the Thai Nguyen to inform item development. Alcohol use was assessed using the Alcohol Use Disorders Identification Test. We tested items in a survey of 1,559 ART clinic patients to assess internal consistency and structural validity. We used log binomial modeling to estimate associations between any reported alcohol abstinence stigma and alcohol use. RESULTS: Using the results from the qualitative interview data, we developed the alcohol abstinence stigma scale with seven final items with scores ranging from 0 (no stigma) to 28 (high stigma). The scale had good internal consistency (α = 0.75). Exploratory factor analysis suggested the presence of three factors: internalized, experienced, and anticipated stigma that explained 56.9% of the total variance. The mean score was 2.74, (SD = 4.28) and 46% reported any alcohol abstinence stigma. We observed a dose-response relationship between alcohol abstinence stigma and alcohol use. PWH who reported any alcohol abstinence stigma had greater hazardous alcohol use (aPR = 1.32, 95% CI: 1.12, 1.56), harmful alcohol use (aPR = 2.26, 95% CI: 1.37, 3.72), and dependence symptoms (aPR = 3.81, 95% CI: 2.19, 6.64). CONCLUSION: Alcohol abstinence stigma is associated with increased alcohol levels of alcohol use among PWH in Vietnam, signaling challenges for alcohol reduction. Consideration of alcohol abstinence stigma will be essential for the design of effective alcohol reduction interventions and policy efforts to prevent adverse health consequences of alcohol use among PWH.

Effect of 2 Integrated Interventions on Alcohol Abstinence and Viral Suppression Among Vietnamese Adults With Hazardous Alcohol Use and HIV: A Randomized Clinical Trial.

Importance: Hazardous and heavy alcohol use is common among people living with HIV and may decrease antiretroviral therapy (ART) adherence, but limited data exist from randomized clinical trials about the effects of interventions on viral load. Objective: To compare the efficacy of 2 scalable ART clinic-based interventions on alcohol use and viral suppression. Design, Setting, and Participants: This 3-group randomized clinical trial was conducted among 440 adults with HIV who were being treated at 7 ART clinics in Thai Nguyen, Vietnam. Adults receiving ART with hazardous alcohol use (Alcohol Use Disorders Identification Test-Consumption score ≥4 for men or ≥3 for women) and no plans to leave Thai Nguyen were included. Data were collected from March 2016 to May 2018 and analyzed from June 2018 to February 2020. Interventions: Participants were randomly assigned (1:1:1) to standard of care (SOC), a combined intervention of motivational enhancement therapy and cognitive behavioral therapy (6 in-person sessions of 1 hour each and 3 optional group sessions), or a brief intervention with similar components as the combined intervention but consisting of 2 shorter in-person sessions and 2 telephone sessions. Main Outcomes and Measures: The primary study outcomes were percentage of days abstinent from alcohol, confirmed using the alcohol biomarker phosphatidylethanol, and viral suppression at 12 months after enrollment. Results: A total of 440 eligible individuals (mean [SD] age, 40.2 [5.8] years; 426 [96.8%] men) were enrolled; 147 (33.4%) were assigned to the combined intervention, 147 (33.4%) to the brief intervention, and 146 (33.2%) to SOC. In the combined intervention group, 112 participants (76.2%) attended all 6 sessions, and in the brief intervention group, 124 (84.4%) attended all 4 sessions; in the whole sample, 390 (88.6%) completed 12 months of follow-up. At 12 months, the mean (SE) percentage of days abstinent was 65% (3.1%) among those in the combined intervention group, 65% (3.2%) among those in the brief intervention group, and 50% (3.4%) among those in the in the SOC group (Cohen d for combined intervention vs SOC and brief intervention vs SOC: 39%; 95% CI, 15% to 64%). Viral suppression (ie, <20 copies of HIV-1 RNA per milliliter) at 12 months was higher after the brief intervention than SOC (difference, 11%; 95% CI, 2% to 20%), but the difference between the combined intervention and SOC was not significantly different (difference, 5%; 95%, CI, -5% to 15%). Conclusions and Relevance: In this study, the brief intervention resulted in a significant increase in percentage of days abstinent from alcohol and a significant increase in viral suppression after 12 months. Future implementation science studies evaluating scale-up of the brief intervention are needed. Trial Registration: ClinicalTrials.gov Identifier: NCT02720237.

Implementation of two alcohol reduction interventions among persons with hazardous alcohol use who are living with HIV in Thai Nguyen, Vietnam: a micro-costing analysis.

BACKGROUND: Hazardous alcohol use is detrimental to persons with HIV (PWH), impacting medication adherence and liver function, yet globally resources to target alcohol use behavior in this population are limited. Few studies have identified the costs of integrating alcohol reduction interventions into HIV care. OBJECTIVE: To estimate the costs of implementing and delivering two evidence-based behavioral counseling interventions targeting hazardous alcohol use among persons with HIV and to estimate the costs of scale-up in ART clinics in Thai Nguyen, Vietnam. METHODS: We undertook a micro-costing approach to determine the costs of delivering two adapted evidence-based interventions to reduce alcohol use: an intensive combined cognitive behavioral therapy and motivational enhancement therapy-informed intervention (CoI) and an abbreviated brief alcohol intervention (BI). A total of 294 participants with hazardous alcohol use were identified through a brief screening tool and received the CoI (n = 147) and the BI (n = 147) over 3 months. We estimated costs using time and motion studies, budget analysis, staff interviews, and participant questionnaires. Data were collected from 2016 to 2018 in VND and converted to USD. RESULTS: The total cost of implementation and administration of the intervention to 147 participants receiving the CoI was $13,900 ($95 per participant) and to 147 participants receiving the BI was $5700 ($39 per participant). Implementation and startup costs including training accounted for 27% of costs for the CoI and 28% for the BI. Counselor costs accounted for a large proportion of both the CoI (41%) and the BI (30%). CONCLUSIONS: Implementing and delivering alcohol reduction interventions to people with HIV in Vietnam with appropriate fidelity is costly. These costs may be reduced, particularly counselor labor costs, by using an evidence-based brief intervention format. Future research should explore the budgetary impact of brief and combined interventions to reduce hazardous alcohol use, particularly among vulnerable populations.

Comparing a standard and tailored approach to scaling up an evidence-based intervention for antiretroviral therapy for people who inject drugs in Vietnam: study protocol for a cluster randomized hybrid type III trial.

BACKGROUND: People who inject drugs (PWID) bear a disproportionate burden of HIV infection and experience poor outcomes. A randomized trial demonstrated the efficacy of an integrated System Navigation and Psychosocial Counseling (SNaP) intervention in improving HIV outcomes, including antiretroviral therapy (ART) and medications for opioid use disorder (MOUD) uptake, viral suppression, and mortality. There is limited evidence about how to effectively scale such intervention. This protocol presents a hybrid type III effectiveness-implementation trial comparing two approaches for scaling-up SNaP. We will evaluate the effectiveness of SNaP implementation approaches as well as cost and the characteristics of HIV testing sites achieving successful or unsuccessful implementation of SNaP in Vietnam. METHODS: Design: In this cluster randomized controlled trial, two approaches to scaling-up SNaP for PWID in Vietnam will be compared. HIV testing sites (n = 42) were randomized 1:1 to the standard approach or the tailored approach. Intervention mapping was used to develop implementation strategies for both arms. The standard arm will receive a uniform package of these strategies, while implementation strategies for the tailored arm will be designed to address site-specific needs. PARTICIPANTS: HIV-positive PWID participants (n = 6200) will be recruited for medical record assessment at baseline; of those, 1500 will be enrolled for detailed assessments at baseline, 12, and 24 months. Site directors and staff at each of the 42 HIV testing sites will complete surveys at baseline, 12, and 24 months. OUTCOMES: Implementation outcomes (fidelity, penetration, acceptability) and effectiveness outcomes (ART, MOUD uptake, viral suppression) will be compared between the arms. To measure incremental costs, we will conduct an empirical costing study of each arm and the actual process of implementation from a societal perspective. Qualitative and quantitative site-level data will be used to explore key characteristics of HIV testing sites that successfully or unsuccessfully implement the intervention for each arm. DISCUSSION: Scaling up evidence-based interventions poses substantial challenges. The proposed trial contributes to the field of implementation science by applying a systematic approach to designing and tailoring implementation strategies, conducting a rigorous comparison of two promising implementation approaches, and assessing their incremental costs. Our study will provide critical guidance to Ministries of Health worldwide regarding the most effective, cost-efficient approach to SNaP implementation. TRIAL REGISTRATION: NCT03952520 on Clinialtrials.gov. Registered 16 May 2019.