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Project GOLD: A pilot randomized controlled trial of a novel psychoeducational HIV/STI prevention intervention for heterosexually-active black youth.

ABSTRACT: Black youth account for the largest number of new HIV infections among heterosexual youth. Mental illness and difficulties in emotion regulation contribute to increased reports of HIV/sexually transmitted infection (STI) risk-related sexual behaviors in this group. Yet limited interventions exist to address this affective component of the sexual decision-making process. The purpose of this paper was to describe the trial design, research challenges, and baseline characteristics from a study designed to fill this gap. Project GOLD was a pilot randomized controlled trial of a psychoeducational HIV/STI prevention intervention designed to address the role of mental illness and emotion regulation in HIV/STI risk among heterosexually-active Black youth aged 14 to 17 (N?=?108). Challenges encountered in the research process warrant further attention in future research (e.g., disagreement among the regulatory bodies on parental permission requirements). The most common mental health diagnoses were Recurrent Major Depressive Disorder (15.7%) and current substance abuse (7.4%). Participants reported higher levels of emotional suppression, and adaptive methods of emotion management, than culturally inappropriate expressions of anger or sadness. They also reported a mean age of 13.6 at first vaginal sex, used condoms 66% of the time for vaginal sex, and had an average of three sexual partners in the past 6 months. More than one-quarter (26.9%) had sex with more than one person in the same day. These findings indicate intervention is crucial for this population. The forthcoming trial evaluation will indicate the promise of such interventions in reducing HIV/STI infections in this key population.

SUBMITTER: Brawner BM

PROVIDER: S-EPMC6913528 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Project GOLD: A pilot randomized controlled trial of a novel psychoeducational HIV/STI prevention intervention for heterosexually-active black youth.

Brawner Bridgette M BM Jemmott Loretta Sweet LS Wingood Gina G Lozano Alicia J AJ Hanlon Alexandra L AL

Research in nursing & health 20190201 1

Black youth account for the largest number of new HIV infections among heterosexual youth. Mental illness and difficulties in emotion regulation contribute to increased reports of HIV/sexually transmitted infection (STI) risk-related sexual behaviors in this group. Yet limited interventions exist to address this affective component of the sexual decision-making process. The purpose of this paper was to describe the trial design, research challenges, and baseline characteristics from a study desi ...[more]

PMID: 30730043

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Project description:BACKGROUND:Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya. OBJECTIVE:The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention. METHODS:The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming. RESULTS:The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3) pre-exposure prophylaxis (PrEP), conditional cash transfer (CCT), and contraceptives for females; and (4) referrals for HIV care among those identified as HIV-positive. The combination package platform selected is mobile health teams in an integrated services delivery model. A cross-sectional analysis will be conducted to determine the uptake of the interventions. To determine long-term impact, the protocol outlines enrolling selected participants in mutually exclusive longitudinal cohorts (HIV-positive, PrEP, CCT, and HIV-negative) followed by using mobile phone text messages (short message service, SMS) and in-person surveys to prospectively assess prevention method uptake, adherence, and risk compensation behaviors. Cross-sectional and sub-cohort analyses will be conducted to determine intervention packages uptake. CONCLUSIONS:The literature review, focus groups, and modeling indicate that offering age- and gender- specific combination HIV prevention interventions that include biomedical, behavioral, and structural interventions can have an impact on HIV risk reduction. Implementing this protocol will show the feasibility of delivering these services at scale. The MP3 Youth study is one of the few combination HIV prevention intervention protocols incorporating youth- and gender-specific interventions in one delivery setting. Lessons learned from the design of the protocol can be incorporated into the national guidance for combination HIV prevention for youth in Kenya and other high-burden SSA settings. TRIAL REGISTRATION:ClinicalTrials.gov NCT01571128; http://clinicaltrials.gov/ct2/show/NCT01571128?term=MP3+youth&rank=1 (Archived by WebCite at http://www.webcitation.org/6nmioPd54).

Project description:INTRODUCTION:Haiti has the highest HIV infection rate in the Western hemisphere, with approximately one in 50 people infected. The January 2010 earthquake led to the collapse of Haiti's social, economic and health infrastructure, exacerbating social and structural HIV risk factors. Internally displaced (ID) women are particularly at high risk for HIV infection due to breakdown of community networks, increased poverty and sexual violence. The authors present the rationale and study protocol for pilot-testing FASY (Famn an Aksyon Pou Santé Yo) (Women Taking Action For Their Health), a psychoeducational HIV/STI prevention intervention with ID women in Haiti. METHODS AND ANALYSIS:This is a single-centre pragmatic N-of-1 pilot study. The target population is ID women in Leogane, Haiti. The authors aim to recruit 200 participants using purposive peer-driven recruitment methods. ID women will be trained as community health workers to deliver the FASY intervention in Kreyol. Participants will conduct a pretest that involves an individual HIV/STI educational video-based component followed by a 6-week group programme of 2 h women's health meetings. The primary outcome is HIV knowledge; our prespecified index of clinically significant change is an effect size of 0.30. Secondary outcomes include: sexually transmitted infections knowledge, condom use, social support, resilient coping, depression and relationship control. Multivariate analysis of variance will be used to compare pretest and post-test differences across variables to assess if the intervention influenced primary or secondary outcomes. Significant multivariate analysis of variance will be followed up with both univariate tests and discriminant function analyses to understand significant effects. ETHICS AND DISSEMINATION:Research Ethics Board approval (2011-0033-E) was attained from the Women's College Hospital, University of Toronto, Toronto, Ontario, Canada. Trial results will be published according to the CONSORT statement, modified for the N-of-1 pilot study design, regardless of the outcomes. TRIAL REGISTRATION NUMBER:This study is registered at http://clinicaltrials.gov, registration number NCT01492829.

Project description:This resident physician-led quality improvement project was conducted with aims to improve the health of youth prescribed atypical antipsychotic medications by increasing physician monitoring for metabolic side effects, while simultaneously educating trainees in quality improvement methodology. The plan, do, study, act quality improvement framework was utilized. Baseline metabolic monitoring rates of patients prescribed atypical antipsychotic medications in the two psychiatry resident outpatient clinics were obtained. Rates were stratified based on time on medication (<1 year, ?1 year) and parameter monitored. Metabolic monitoring rates subsequent to targeted changes were obtained. Problem solving with residents revealed barriers to monitoring, such as limited awareness of specific guideline recommendations and lack of convenient access to medical equipment (calibrated scales). Residents received education about atypical antipsychotic monitoring guidelines and side effect treatment. Residents were provided with calibrated scales. Atypical antipsychotic monitoring templates were introduced. Online surveys using were conducted to determine self-reported baseline-monitoring rates and comfort with guidelines following targeted change. The baseline metabolic monitoring rates of patients prescribed atypical antipsychotic medications was 9% (range: 0 to 17.6%) for youth in their first year taking an atypical antipsychotic medication and 58.9% (range: 29% to 100%) in subsequent years on medication. The results of relatively easy changes resulted in modest improvement in monitoring rates. The metabolic monitoring rate of a patient initiated on an atypical antipsychotic medication was 29% after targeted quality improvement measures were employed. Following quality improvement changes, residents reported increased knowledge about guidelines and increased monitoring for side effects. Use of a standardized data collection instrument to track monitoring of patients increased from 0% to 70% (range: 30% to 90%). Quality improvement projects provide an avenue with which to improve atypical antipsychotic monitoring rates. Through active participation in quality improvement projects, psychiatry residents may be taught to employ quality improvement methodology.

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Project GOLD: A pilot randomized controlled trial of a novel psychoeducational HIV/STI prevention intervention for heterosexually-active black youth.

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Project GOLD: A pilot randomized controlled trial of a novel psychoeducational HIV/STI prevention intervention for heterosexually-active black youth.

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