NCT03340428

Brief Summary

HIV remains the leading cause of death in South Africa as a result of a failure of people living with HIV to seek HIV treatment and be retained in care. After initiating antiretroviral therapy while incarcerated, most ex-inmates fail to remain engaged in care. The goal of this research is to reduce mortality, morbidity, and HIV transmission by developing an actionable approach to retaining these individuals in HIV care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 9, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
5 months until next milestone

Results Posted

Study results publicly available

April 27, 2021

Completed
Last Updated

June 26, 2025

Status Verified

March 1, 2021

Enrollment Period

1.4 years

First QC Date

November 8, 2017

Results QC Date

March 31, 2021

Last Update Submit

June 24, 2025

Conditions

HivAdherence, Patient

Keywords

incarcerationlinkage to careretention in care

Outcome Measures

Primary Outcomes (1)

  • Number of Participants in Care at Six Months

    Self-reported in TCAC or routine DoH clinical care

    6 months after corrections release

Secondary Outcomes (10)

  • Proportion of Participants Verified in Care at Six Months

    6 months after corrections release

  • Time to Linkage to HIV Care

    6 months after corrections release

  • Proportion of Participants Linked to Care Within 90 Days of Corrections Release

    90 days after corrections release

  • Viral Suppression (HIV RNA <400 c/mL) at Six Months

    6 months after corrections release

  • Difference in Bonding Social Capital Score at Six Months

    6 months after corrections release

  • +5 more secondary outcomes

Study Arms (2)

Transition Community Adherence Club (TCAC)

EXPERIMENTAL

Participants in this arm will be referred to join a facilitated group setting for HIV on release from incarceration. This arm will provide HIV care services in a facilitated group setting to provide medical and psychosocial needs of participants.

Behavioral: Transition Community Adherence Club (TCAC)

Care as usual (CAU)

NO INTERVENTION

Care as usual participants will be referred to routine clinic HIV care on release from corrections.

Interventions

Transition Community Adherence Club (TCAC)BEHAVIORAL

A behavioral intervention targeting stigma and care challenges through care delivery, social capital through a group setting, improved job prospects through referrals and training, and substance use through referrals. Participants assigned to this group will meet at least every month in a group of 5-15 members for approximately 2 hours. During the meeting there will be facilitated group discussion, an interactive curriculum including life skills, economic skills, HIV and health, and disclosure and stigma. Individual health screening and distribution of prepackaged medications conclude the session. Individual referrals for specific services (e.g. mental health or substance use management) will be available.

Also known as: Transition Community Adherence Club
Transition Community Adherence Club (TCAC)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently incarcerated (either an offender/sentenced inmates or awaiting trial inmate/remandee)
  • Housed at one of the study correctional facilities (including participating satellite centres)
  • Diagnosed with HIV
  • Currently receiving antiretroviral therapy
  • Anticipated release or trial date within 3 months of study enrollment
  • Self-report expected to reside within Ekurhuleni, Tshwane, or Johannesburg districts of Gauteng Province and within proximity to one of the TCAC sites (within 20 km, 45 minute travel time, or two local taxi minibus rides)
  • Agree to post-discharge follow-up
  • Medically stable based on DCS health assessment (including not pregnant)
  • On antiretroviral therapy (ART) for \>3 months at the expected time of corrections release

You may not qualify if:

  • Failure to provide informed consent to be followed up by study staff after release
  • Unable to speak one of the study languages (English, Sesotho, isiXhosa, isiZulu, Setswana, Xitsonga, and Afrikaans)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Correctional Services

Pretoria West, Pretoria, 0001, South Africa

Location

Related Publications (1)

  • Mabuto T, Woznica DM, Ndini P, Moyo D, Abraham M, Hanrahan C, Charalambous S, Zack B, Baral S, Owczarzak J, Hoffmann CJ. Transitional community adherence support for people leaving incarceration in South Africa: a pragmatic, open-label, randomised controlled trial. Lancet HIV. 2024 Jan;11(1):e11-e19. doi: 10.1016/S2352-3018(23)00235-7. Epub 2023 Dec 7.

    PMID: 38071994DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromePatient Compliance

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Christopher Hoffmann
Organization
Johns Hopkins University
choffmann@jhmi.edu
410-614-4257

Study Officials

  • Christopher Hoffmann, MD, MPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Intervention arm will be masked to the field researchers and the investigators until unblinding during final analysis.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Individually randomized trial with 2:1 allocation to the intervention compared to care as usual
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2017

First Posted

November 13, 2017

Study Start

March 9, 2019

Primary Completion

August 1, 2020

Study Completion

November 30, 2020

Last Updated

June 26, 2025

Results First Posted

April 27, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

De-identified trial data will be made available one year after completion of all study activities.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
One year after completion of study activities.
Access Criteria
Contact PI

Locations

ZA(1)