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A Randomized Controlled Trial of Rise, a Community-Based Culturally Congruent Adherence Intervention for Black Americans Living with HIV.

ABSTRACT: BACKGROUND:Evidence-based HIV treatment adherence interventions have typically shown medium-sized effects on adherence. Prior evidence-based HIV treatment adherence interventions have not been culturally adapted specifically for Black/African Americans, the population most affected by HIV disparities in the USA, who exhibit lower adherence than do members of other racial/ethnic groups. PURPOSE:We conducted a randomized controlled trial of Rise, a 6-month culturally congruent adherence counseling intervention for HIV-positive Black men and women. METHODS:Rise was delivered by a trained peer counselor who used a problem-solving approach to address culturally congruent adherence barriers (e.g., medical mistrust, HIV stigma) and assisted with linkage to supportive services. A total of 215 participants were randomized to the intervention group (n = 107) or a wait-list control group (n = 108). Adherence was assessed daily via electronic monitoring. RESULTS:In a repeated measures multivariate logistic regression model of dichotomous adherence (using a clinically significant cutoff of 85% of doses taken), adjusted for sociodemographic and medical covariates, adherence in the intervention group improved over time relative to the control group, (OR = 1.30 per month (95% CI = 1.12-1.51), p < 0.001), representing a large cumulative effect after 6 months (OR = 4.76, Cohen's d = 0.86). CONCLUSIONS:Rise showed a larger effect on adherence than prior HIV adherence intervention studies. For greater effectiveness, interventions to improve adherence among Black people living with HIV may need to be customized to address culturally relevant barriers to adherence. ( ClinicalTrials.gov #NCT01350544).

SUBMITTER: Bogart LM

PROVIDER: S-EPMC5650942 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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A Randomized Controlled Trial of Rise, a Community-Based Culturally Congruent Adherence Intervention for Black Americans Living with HIV.

Bogart Laura M LM Mutchler Matt G MG McDavitt Bryce B Klein David J DJ Cunningham William E WE Goggin Kathy J KJ Ghosh-Dastidar Bonnie B Rachal Nikki N Nogg Kelsey A KA Wagner Glenn J GJ

Annals of behavioral medicine : a publication of the Society of Behavioral Medicine 20171201 6

<h4>Background</h4>Evidence-based HIV treatment adherence interventions have typically shown medium-sized effects on adherence. Prior evidence-based HIV treatment adherence interventions have not been culturally adapted specifically for Black/African Americans, the population most affected by HIV disparities in the USA, who exhibit lower adherence than do members of other racial/ethnic groups.<h4>Purpose</h4>We conducted a randomized controlled trial of Rise, a 6-month culturally congruent adher ...[more]

PMID: 28432578

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Project description:IntroductionCurrent diabetes self-management programs are often insufficient to improve outcomes for African Americans because of a limited focus on medication adherence and addressing culturally influenced beliefs about diabetes and medicines. This study evaluated the feasibility and acceptability of a novel culturally tailored diabetes self-management intervention that addressed key psychosocial and sociocultural barriers to medication adherence for African Americans.MethodsThe intervention consisted of group education and race-congruent peer-based phone support. Three African Americans who were engaged in taking their diabetes medicines (ambassadors), were matched with 8 African Americans who were not engaged in taking medicines (buddies). We conducted a single group, pre/post study design with African Americans with type 2 diabetes. Wilcoxon signed rank tests assessed mean score differences in outcomes at baseline compared with 6-months follow-up. Semi-structured interviews explored buddies' acceptability of the intervention.ResultsBuddies and ambassadors were similar in age and mostly female. Recruitment rates were 80% for buddies and 100% for ambassadors. Retention rate for primary outcomes was 75%. Buddies had a mean completion of 13.4/17 of sessions and phone calls. Ambassadors completed 84% of intervention calls with buddies. Although there were no statistically significant differences in mean A1C and medication adherence, we found a clinically meaningful decrease (-0.7) in mean A1C at the 6-month follow up compared to baseline. Secondary outcomes showed signal of changes. Themes showed buddies perceived an improvement in provider communication, learned goal setting strategies, and developed motivation, and confidence for self-management. Buddies perceived the program as acceptable and culturally appropriate.ConclusionThis culturally tailored diabetes self-management intervention that addresses diabetes self-management, psychosocial and behavioral barriers to medication adherence, and incorporates race-congruent peer support from African Americans engaged in taking medicines seemed feasible and acceptable. The results provide support for a fully powered randomized trial to test the intervention's efficacy.Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT04857411.Date of registrationApril 23, 2021.

Project description:BackgroundAdherence to HIV care is complex, as barriers to care are multidimensional, particularly for ethnic minority women. Mobile health (mHealth) solutions are supportive in improving HIV health care outcomes. In the United States, however, mHealth interventions are not widely implemented in public HIV clinics and have not been customized for women. There is an unmet need for culturally and linguistically appropriate mHealth interventions that address the health care needs of minority women living with HIV.ObjectiveThis study aims to describe a protocol investigating the feasibility of an mHealth intervention for treatment adherence among women living with HIV. This is a two-phase, mixed methods, pilot randomized controlled trial that begins with qualitative patient interviews to inform the system design. Participants will be block randomized by language (English, Spanish, and Haitian Creole) to 1 of 2 study arms.MethodsWomen (age ≥18 years) who were followed up at the women's HIV clinic of an academic medical center, with a recent history of nonadherence to HIV care (missed appointments, unsuppressed viral load, or not taking medications as prescribed), will be enrolled. The experimental arm will receive the intervention, which includes health reminders and psychoeducational messaging, plus clinical standard of care reminders. The psychoeducational messaging will target patient-level barriers of HIV stigma and medical mistrust and resilience as a patient-level strength. The control arm will receive standard of care reminders only (ie, mailed appointments and automated telephone calls). All aspects of the study and intervention will be offered in the participants' preferred language. The primary outcome is the feasibility and acceptability of the study. The secondary outcomes are changes in self-reported medication adherence, depression symptoms, HIV stigma, medical mistrust, resilience, and clinic attendance and viral suppression extracted from the participants' medical records. Data will be assessed at baseline (T0) and 2 subsequent clinic visits-approximately 3 to 4 months from the baseline (time 1; T1) and 6 to 9 months from the baseline (time 2; T2). Qualitative data will be transcribed and analyzed iteratively. Bivariate analyses will compare data by the study group (chi-square, odds ratios, and t tests). Exploratory analyses will be conducted for each outcome variable-T1 and T2 values will be compared with values at T0 by the study group.ResultsAs of March 2020, baseline quantitative data were collected on 54 participants (28 English speakers, 14 Spanish speakers, and 12 Haitian Creole speakers). The first 3 focus groups (1 in each of the 3 languages) were completed, with a total of 20 participants. The findings are currently being integrated into the beta version of the mHealth texting system.ConclusionsThe findings of this novel HIV adherence intervention may shed light on the barriers and facilitators of HIV health care and the mechanisms of an mHealth intervention that is customized for ethnic minority women living with HIV.Trial registrationClinicalTrials.gov NCT03738410; https://clinicaltrials.gov/ct2/show/NCT03738410.International registered report identifier (irrid)DERR1-10.2196/17656.

Project description:ImportanceConcentrated epidemics of HIV and sexually transmitted infections (STIs) have persisted among Black women in community supervision programs (CSPs) in the United States. Accumulating research has highlighted the effectiveness of culturally tailored HIV/STI interventions for Black women; however, there is a dearth of such interventions for the large number of Black women in CSPs.ObjectiveTo determine the effectiveness of a 5-session culturally tailored group-based intervention (Empowering African-American Women on the Road to Health [E-WORTH]) with individualized computerized modules and streamlined HIV testing in reducing STIs and condomless sex vs a 1-session streamlined HIV testing control condition.Design, setting, and participantsThis randomized clinical trial was conducted from November 18, 2015, (first recruitment) to August 20, 2019 (last 12-month follow-up). Black women mandated to probation, parole, or alternative-to-incarceration programs in New York City who had a history of drug use were recruited and randomized to receive either E-WORTH or a streamlined HIV testing control condition. Both conditions were delivered by Black female staff at a large CSP. The analysis took an intention-to-treat approach.InterventionE-WORTH included a 1-hour individual HIV testing and orientation session and 4 weekly 90-minute group sessions. The control condition included one 30-minute session of HIV testing and information.Main outcomes and measuresPrimary outcomes were incidence of any STI (biologically assayed chlamydia, gonorrhea, and Trichomonas vaginalis) at the 12-month assessment and the number of condomless acts of vaginal or anal intercourse in the past 90 days during the 12-month period.ResultsA total of 352 participants who identified as Black or African American were enrolled, including 79 (22.5%) who also identified as Latinx. The mean (SD) age was 32.4 (11.0) years. A total of 172 participants (48.9%) were assigned to the E-WORTH condition, and 180 (51.1%) were assigned to the control condition. Compared with control participants, participants assigned to the E-WORTH condition had 54% lower odds of testing positive for any STI at the 12-month follow-up (odds ratio, 0.46; 95% CI, 0.25-0.88; P = .01) and reported 38% fewer acts of condomless vaginal or anal intercourse during the 12-month period (incidence rate ratio, 0.62; 95% CI, 0.39-0.97; P = .04).Conclusions and relevanceThe magnitudes of effects found across biological and behavioral outcomes in this randomized clinical trial indicate the feasibility and effectiveness of implementing E-WORTH in real-world CSPs. The findings lend further evidence to the promise of culturally tailored HIV/STI interventions for Black women.Trial registrationClinicalTrials.gov Identifier: NCT02391233.

Dataset Information

A Randomized Controlled Trial of Rise, a Community-Based Culturally Congruent Adherence Intervention for Black Americans Living with HIV.

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A Randomized Controlled Trial of Rise, a Community-Based Culturally Congruent Adherence Intervention for Black Americans Living with HIV.

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