Dataset Information

Rationale, study design and sample characteristics of a randomized controlled trial of directly administered antiretroviral therapy for HIV-infected prisoners transitioning to the community - a potential conduit to improved HIV treatment outcomes.

ABSTRACT:

Background

HIV-infected prisoners experience poor HIV treatment outcomes post-release. Directly administered antiretroviral therapy (DAART) is a CDC-designated, evidence-based adherence intervention for drug users, yet untested among released prisoners.

Methods

Sentenced HIV-infected prisoners on antiretroviral therapy (ART) and returning to New Haven or Hartford, Connecticut were recruited and randomized 2:1 to a prospective controlled trial (RCT) of 6 months of DAART versus self-administered therapy (SAT); all subjects received case management services. Subjects meeting DSM-IV criteria for opioid dependence were offered immediate medication-assisted treatment. Trained outreach workers provided DAART once-daily, seven days per week, including behavioral skills training during the last intervention month. Both study groups were assessed for 6 months after the intervention period. Assessments occurred within 90 days pre-release (baseline), day of release, and then monthly for 12 months. Viral load (VL) and CD4 testing was conducted baseline and quarterly; genotypic resistance testing was conducted at baseline, 6 and 12 months. The primary outcome was pre-defined as viral suppression (VL<400 copies/mL) at 6 months.

Results

Between 2004 and 2009, 279 participants were screened, of which 202 met eligibility criteria and 154 were ultimately enrolled in the study; 103 subjects were randomized to DAART and 51 to SAT. Subjects were mostly male (81.2%), people of color (87.0%), had an alcohol use disorder (39.7%), had underlying depression (54.2%), were virally suppressed (78.8%) and had a mean CD4=390.7 cells/mL.

Conclusions

Outcomes from this RCT will contribute greatly to HIV treatment outcomes after release from prison, a period associated with adverse HIV and other medical consequences.

SUBMITTER: Saber-Tehrani AS

PROVIDER: S-EPMC3268833 | biostudies-literature | 2012 Mar

REPOSITORIES: biostudies-literature

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Publications

Rationale, study design and sample characteristics of a randomized controlled trial of directly administered antiretroviral therapy for HIV-infected prisoners transitioning to the community - a potential conduit to improved HIV treatment outcomes.

Saber-Tehrani Ali Shabahang AS Springer Sandra A SA Qiu Jingjun J Herme Maua M Wickersham Jeffrey J Altice Frederick L FL

Contemporary clinical trials 20111112 2

<h4>Background</h4>HIV-infected prisoners experience poor HIV treatment outcomes post-release. Directly administered antiretroviral therapy (DAART) is a CDC-designated, evidence-based adherence intervention for drug users, yet untested among released prisoners.<h4>Methods</h4>Sentenced HIV-infected prisoners on antiretroviral therapy (ART) and returning to New Haven or Hartford, Connecticut were recruited and randomized 2:1 to a prospective controlled trial (RCT) of 6 months of DAART versus self ...[more]

PMID: 22101218

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Project description:BackgroundDepression is highly prevalent among HIV-infected injection drug users (IDUs) and has been associated with poor adherence to antiretroviral therapy and increased morbidity and mortality. Factors associated with changes in depressive symptoms among this group receiving antiretroviral treatment that have not been extensively evaluated.MethodsThis post-hoc analysis of prospective clinical trial analyzes the factors associated with changes in depressive symptomatology using the Center for Epidemiologic Studies of Depression Scale (CES-D) among HIV-infected IDUs enrolled in a prospective, six months randomized controlled trial of directly administered antiretroviral therapy (DAART) versus self-administered therapy.ResultsOf the 127 evaluable IDUs enrolled in the study, 89 subjects (70%) had complete six-month follow-up data. Of these, 58 (63%) met baseline criteria for severe or major depressive disorder (MDD) using the CES-D. CES-D scores improved significantly from baseline to six months overall for the 89 subjects (p=0.01) and for the 58 who had MDD with six-month data (p=0.001). Using multiple regression, an improvement in CES-D score was independently associated with: (1) increase in CD4 count; (2) increase in adherence; (3) non-Caucasian race; and (4) older age. Worsening in CES-D score was associated with: (1) increase in HIV-1 RNA levels; (2) homelessness; (3) poor self-efficacy; (4) active drug use; and (5) male gender. Factors not correlated with changes in CES-D were receipt of DAART, engagement in drug treatment, use of antidepressant medication, and employment. Using generalized estimating equation modeling, factors that remained positively associated with improvements in CES-D score were absence of drug use at six months, having housing, higher self-efficacy, increase in CD4 count and increases in adherence.ConclusionImprovements in depressive symptoms could occur with improvement of alterable factors that are associated with strengthening adherence such as linkages to case management, mental health and substance abuse treatment services as well as through enhancement of social stabilization factors through social support and supportive housing.

Project description:BackgroundEarly initiation of antiretroviral therapy (ART) reduces the development of acquired immunodeficiency syndrome (AIDS), non-AIDS related comorbidities and mortality, and prevents transmission. However, the prevalence of delayed ART initiation amongst prisoners in sub-Saharan African countries is high and the contributing factors to this are relatively unknown.MethodsQualitative interviewing was employed to understand the prisoners' lived world with regard to initiating ART and associated barriers and facilitators in the South Ethiopian prison system. We interviewed seven (five male and two female) inmates living with HIV (ILWH) and eleven stakeholders who had a role in human immunodeficiency virus (HIV) care provision for incarcerated people. A phenomenological approach was used to analyse the interview data in which meaning attributed to the lived experiences of the participants was abstracted.ResultsIn this study, participants discussed both barriers to, and facilitators of, early ART initiation during incarceration. The barriers included a lack of access to voluntary counselling and testing (VCT) services, poor linkage to care due to insufficient health staff training, uncooperative prison security systems and loss of privacy regarding disclosure of HIV status. Insufficient health staff training and uncooperative prison security systems both contributed to a loss of patient privacy, ultimately resulting in treatment refusal. Although most participants described the importance of peer education and support for enhancing HIV testing and treatment programs amongst prisoners, there had been a decline in such interventions in the correctional facilities. Service providers suggested opportunities that a prison environment offers for identification and treatment of HIV infected individuals and implementation of peer education programs.ConclusionsOur study identified crucial barriers to and facilitators of early ART initiation amongst prisoners, a key HIV priority population group. Interventions that address the barriers while strengthening the facilitators may enhance a greater utilisation of ART.

Dataset Information

Rationale, study design and sample characteristics of a randomized controlled trial of directly administered antiretroviral therapy for HIV-infected prisoners transitioning to the community - a potential conduit to improved HIV treatment outcomes.

Background

Methods

Results

Conclusions

Publications

Rationale, study design and sample characteristics of a randomized controlled trial of directly administered antiretroviral therapy for HIV-infected prisoners transitioning to the community - a potential conduit to improved HIV treatment outcomes.

Similar Datasets

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