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Prevention of alcohol consumption and transmission of human immunodeficiency virus: randomized clinical trial.

ABSTRACT: OBJECTIVE:to know the effects of a nursing intervention to reduce alcohol use and risk factors for transmission of human immunodeficiency virus (HIV). METHOD:randomized single-blinded clinical trial performed by nurses with young women. The study included 66 participants in the intervention group and 66 participants in the control group. The instruments were the Alcohol Use Disorders Identification Test, the HIV Risk Behavior Knowledge and the Condom Use Self-efficacy Scale. Analysis of variance was used. RESULTS:alcohol involvement decreased in the intervention group (F (1.119) = 50.28; p < 0.001; ?2p = 0.297), while HIV knowledge (F (1.130) = 34.34; p < 0.001; ?2p = 0.209) and condom use self-efficacy increased (F (1.129) = 27.20; p < 0.001; ?2p = 0.174). In addition, less participants consumed alcohol in the past week compared to the control group (?2 = 15.95; p < 0.001). CONCLUSION:the nursing intervention had positive effects, which could help young women stay away from alcohol use and the risk of sexually transmitted infections. NCT: 02405481.

SUBMITTER: Mendez-Ruiz MD

PROVIDER: S-EPMC7217628 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Prevention of alcohol consumption and transmission of human immunodeficiency virus: randomized clinical trial.

Mendez-Ruiz Martha Dalila MD Villegas-Pantoja Miguel Angel MA Alarcón-Luna Nohemí Selene NS Villegas Natalia N Cianelli Rosina R Peragallo-Montano Nilda N

Revista latino-americana de enfermagem 20200511

<h4>Objective</h4>to know the effects of a nursing intervention to reduce alcohol use and risk factors for transmission of human immunodeficiency virus (HIV).<h4>Method</h4>randomized single-blinded clinical trial performed by nurses with young women. The study included 66 participants in the intervention group and 66 participants in the control group. The instruments were the Alcohol Use Disorders Identification Test, the HIV Risk Behavior Knowledge and the Condom Use Self-efficacy Scale. Analy ...[more]

PMID: 32401905

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Project description:Behavioral change interventions have demonstrated short-term efficacy in reducing sexually transmitted infection (STI)/human immunodeficiency virus (HIV) risk behaviors; however, few have demonstrated long-term efficacy.To evaluate the efficacy of a telephone counseling prevention maintenance intervention (PMI) to sustain STI/HIV-preventive behaviors and reduce incident STIs during a 36-month follow-up.In a 2-arm randomized supplemental treatment trial at 3 clinics serving predominantly minority adolescents in Atlanta, Georgia, 701 African American adolescent girls aged 14 to 20 years received a primary treatment and subsequently received a different (supplemental) treatment (PMI) to enhance effects of the primary treatment.Participants in the experimental condition (n?=?342) received an adapted evidence-based STI/HIV intervention (HORIZONS) and a PMI consisting of brief telephone contacts every 8 weeks over 36 months to reinforce and complement prevention messages. Comparison-condition participants (n?=?359) received HORIZONS and a time- and dose-consistent PMI focused on general health.The primary outcomes were percentage of participants with a laboratory-confirmed incident chlamydial infection and percentage of participants with a laboratory-confirmed gonococcal infection during the 36-month follow-up. Behavioral outcomes included the following: (1) proportion of condom-protected sexual acts in the 6 months and 90 days prior to assessments; (2) number of sexual episodes during the past 90 days in which participants engaged in sexual intercourse while high on drugs and/or alcohol; and (3) number of vaginal sex partners in the 6 months prior to assessments.During the 36-month follow-up, fewer participants in the experimental condition than in the comparison condition had incident chlamydial infections (94 vs 104 participants, respectively; risk ratio?=?0.50; 95% CI, 0.28 to 0.88; P?=?.02) and gonococcal infections (48 vs 54 participants, respectively; risk ratio?=?0.40; 95% CI, 0.15 to 1.02; P?=?.06). Participants completing more telephone contacts had a lower risk of chlamydial infection (risk ratio?=?0.95; 95% CI, 0.90 to 1.00; P?=?.05). Participants in the experimental condition reported a higher proportion of condom-protected sexual acts in the 90 days (mean difference?=?0.08; 95% CI, 0.06 to 0.11; P?=?.02) and 6 months (mean difference?=?0.08; 95% CI, 0.06 to 0.10; P?=?.04) prior to assessments and fewer episodes of sexual acts while high on drugs and/or alcohol (mean difference?=?-0.61; 95% CI, -0.98 to -0.24; P?<?.001).Sustaining the long-term impact of an STI/HIV intervention is achievable with brief, tailored telephone counseling.clinicaltrials.gov Identifier: NCT00279799.

Project description:Background and aimsCulturally relevant and feasible interventions are needed to address limited professional resources in sub-Saharan Africa for behaviorally treating the dual epidemics of HIV and alcohol use disorder. This study tested the efficacy of a cognitive-behavioral therapy (CBT) intervention to reduce alcohol use among HIV-infected outpatients in Eldoret, Kenya.DesignRandomized clinical trial.SettingA large HIV outpatient clinic in Eldoret, Kenya, affiliated with the Academic Model Providing Access to Healthcare collaboration.ParticipantsA total of 614 HIV-infected outpatients [312 CBT; 302 healthy life-styles (HL); 48.5% male; mean age: 38.9 years; mean education 7.7 years] who reported a minimum of hazardous or binge drinking.Intervention and comparatorA culturally adapted six-session gender-stratified group CBT intervention compared with HL education, each delivered by paraprofessionals over six weekly 90-minute sessions with a 9-month follow-up.MeasurementsPrimary outcome measures were percentage of drinking days (PDD) and mean drinks per drinking day (DDD) computed from retrospective daily number of drinks data obtained by use of the time-line follow-back from baseline to 9 months post-intervention. Exploratory analyses examined unprotected sex and number of partners.FindingsMedian attendance was six sessions across condition. Retention at 9 months post-intervention was high and similar by condition: CBT 86% and HL 83%. PDD and DDD marginal means were significantly lower in CBT than HL at all three study phases. Maintenance period, PDD - CBT = 3.64 (0.696), HL = 5.72 (0.71), mean difference 2.08, 95% confidence interval (CI) = 0.13 - 4.04; DDD - CBT = 0.66 (0.96), HL = 0.98 (0.098), mean difference = 0.31, 95% CI = 0.05 - 0.58. Risky sex decreased over time in both conditions, with a temporary effect for CBT at the 1-month follow-up.ConclusionsA cognitive-behavioral therapy intervention was more efficacious than healthy lifestyles education in reducing alcohol use among HIV-infected Kenyan outpatient drinkers.

Project description:BackgroundInflammation is associated with end-organ disease and mortality for people with human immunodeficiency virus (PWH). Ruxolitinib, a Jak 1/2 inhibitor, reduces systemic inflammation for individuals without human immunodeficiency virus (HIV) and HIV reservoir markers ex vivo. The goal of this trial was to determine safety and efficacy of ruxolitinib for PWH on antiretroviral therapy (ART).MethodsAIDS Clinical Trials Group (ACTG) A5336 was an open-label, multisite, randomized controlled trial (RCT). Participants were randomly assigned (2:1) using centralized software to ruxolitinib (10 mg twice daily) plus stable ART for 5 weeks vs ART alone, stratified by efavirenz use. Eligible participants were suppressed on ART for ≥2 years, without comorbidities, and had >350 CD4+ T cells/µL. Primary endpoints were premature discontinuation, safety events, and change in plasma interleukin 6 (IL-6). Secondary endpoints included other measures of inflammation/immune activation and HIV reservoir.ResultsSixty participants were enrolled from 16 May 2016 to 10 January 2018. Primary safety events occurred in 2.5% (1 participant) for ruxolitinib and 0% for controls (P = .67). Three participants (7.5%) prematurely discontinued ruxolitinib. By week 5, differences in IL-6 (mean fold change [FC], 0.93 vs 1.10; P = .18) and soluble CD14 (mean FC, 0.96 vs 1.08; relative FC, 0.96 [90% confidence interval {CI}, .90-1.02]) levels for ruxolitinib vs controls was observed. Ruxolitinib reduced CD4+ T cells expressing HLA-DR/CD38 (mean difference, -0.34% [90% CI, -.66% to -.12%]) and Bcl-2 (mean difference, -3.30% [90% CI, -4.72% to -1.87%]).ConclusionsIn this RCT of healthy, virologically suppressed PWH on ART, ruxolitinib was well-tolerated. Baseline IL-6 levels were normal and showed no significant reduction. Ruxolitinib significantly decreased markers of immune activation and cell survival. Future studies of Jak inhibitors should target PWH with residual inflammation despite suppressive ART.Clinical trials registrationNCT02475655.

Project description:BackgroundA vaccine to decrease transmission of human immunodeficiency virus type 1 (HIV-1) during breast-feeding would complement efforts to eliminate infant HIV-1 infection by antiretroviral therapy. Relative to adults, infants have distinct immune development, potentially high-risk of transmission when exposed to HIV-1 and rapid progression to AIDS when infected. To date, there have been only three published HIV-1 vaccine trials in infants.Trial designWe conducted a randomized phase I clinical trial PedVacc 001 assessing the feasibility, safety and immunogenicity of a single dose of candidate vaccine MVA.HIVA administered intramuscularly to 20-week-old infants born to HIV-1-negative mothers in The Gambia.MethodsInfants were followed to 9 months of age with assessment of safety, immunogenicity and interference with Expanded Program on Immunization (EPI) vaccines. The trial is the first stage of developing more complex prime-boost vaccination strategies against breast milk transmission of HIV-1.ResultsFrom March to October 2010, 48 infants (24 vaccine and 24 no-treatment) were enrolled with 100% retention. The MVA.HIVA vaccine was safe with no difference in adverse events between vaccinees and untreated infants. Two vaccine recipients (9%) and no controls had positive ex vivo interferon-γ ELISPOT assay responses. Antibody levels elicited to the EPI vaccines, which included diphtheria, tetanus, whole-cell pertussis, hepatitis B virus, Haemophilus influenzae type b and oral poliovirus, reached protective levels for the vast majority and were similar between the two arms.ConclusionsA single low-dose of MVA.HIVA administered to 20-week-old infants in The Gambia was found to be safe and without interference with the induction of protective antibody levels by EPI vaccines, but did not alone induce sufficient HIV-1-specific responses. These data support the use of MVA carrying other transgenes as a boosting vector within more complex prime-boost vaccine strategies against transmission of HIV-1 and/or other infections in this age group.Trial registrationClinicalTrials.gov NCT00982579. The Pan African Clinical Trials Registry PACTR2008120000904116.

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Prevention of alcohol consumption and transmission of human immunodeficiency virus: randomized clinical trial.

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Prevention of alcohol consumption and transmission of human immunodeficiency virus: randomized clinical trial.

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