Retention in CareSPARCSNCT06027671
Structured Peer-delivered ART and Reentry Community Strategy
A study testing Full-SPARCS Intervention in people with Retention in Care, run by Johns Hopkins University at 1 site in South Africa.
Trial summary
The overarching goal of this study is to implement a transition community adherence club strategy (Full-SPARCS) for HIV-positive individuals transitioning from correctional to community settings in South Africa. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retention in Care
- What is being tested?
- Full-SPARCS Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSouth Africa
- Study dates
- 18 Nov 2024to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Incarcerated at one of the participating study enrolment sites, awaiting trial (un-sentenced) and sentenced individuals.
- Diagnosed with HIV and ART at the time of enrolment.
- Anticipated release or trial date within three months of study enrolment.
- Self-report expected to reside in an unrestricted environment within Ekurhuleni, Tshwane, or Johannesburg districts of Gauteng Province and within proximity to one of the SPARCS intervention sites (i.e., within 20km, 45-minute travel time, or two local taxi minibus rides)
- Willing to participate in study post-release follow-up activities and provide contact information for post-release follow-up.
Who cannot join
- <18 years of age.
- Condition (severe cognitive dysfunction or mental illness) rendering the individual unable to provide informed consent.
- Unable to provide informed consent to participate in the study.
- Assessment by DCS health staff indicating that the individual requires a high intensity of care exceeding that which can be provided in a differentiated model of care setting.
- Not released from the correctional facility during the period of intervention delivery.
- Release to a region outside of Gauteng.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tonderai Mabuto contact
South Africa1 site, 1 recruiting
- Recruiting
The Aurum Institute - Head office
Johannesburg, Gauteng, 2193
Pretty Ndini, Masters, +27793611894, pndini@auruminstitute.org
About this study
Official title: Structured Peer-delivered Antiretroviral Therapy (ART) and Reentry Community Strategy to Overcome Barriers to HIV Care Continuity During Community Re-entry From Incarceration in South Africa
The overarching goal of this study is to implement a transition community adherence club strategy (Full-SPARCS) for HIV-positive individuals transitioning from correctional to community settings in South Africa. The investigators seek to provide actionable findings to inform policy decisions to contribute to HIV care continuity with this population. The investigators note that effectiveness and scalability often conflict with intervention design; thus, the investigators have proposed testing whether a group approach is effective and the investigators will assess the costs of each component
- To compare the effectiveness of Full-SPARCS to care as usual to achieve HIV RNA suppression 6 months following correctional facility release
- To assess determinants of implementation of Full-SPARCS
- To assess the scalability through costing and cost effectiveness analysis of Full-SPARCS
Read the detailed description
Background: The South African government has devoted resources towards HIV care in correctional facilities that have resulted in antiretroviral therapy (ART) coverage of >90% and viral load (VL) suppression of >80% among incarcerated people living with HIV (PLWH). However, despite free post-release care, the investigators previously observed that only an estimated 34% were in care three months post-release. The investigators developed, tested, and manualized the Structured Peer-delivered ART and Re-entry Community Strategy (SPARCS) to overcome post-incarceration barriers specific to PLWH returning to the community.8-10 In the investigators randomized controlled pilot of SPARCS, 6-month post-release, continuity of care was 61% in the intervention arm compared to 36% in the usual care arm (p=0.001), demonstrating effectiveness. Full-SPARCS involves 12 biweekly peer facilitator-led group sessions spanning six months post-release. Full-SPARCS is designed to increase self-efficacy, social support, and life skills through facilitated group discussion and curriculum including planning, problem solving, financial literacy, and living with HIV.
Methods: This research study will be conducted in Gauteng Province. Recruitment will occur within correctional facilities of the Department of Correctional Services (DCS) - Modderbee, Kgosi Mampuru II, and Johannesburg. All study interventions will occur following release in either Ekurhuleni District, Tshwane District or Johannesburg District. The study population will be comprised of adult (≥18 years old) corrections inmates, either male or female, with known HIV infection and are receiving ART within the correctional facility and are expected to be released back into the community within 3 months of study enrollment Participants will be randomized 1:1 to either the standard of care or Full-SPARCS using sequential envelopes with study arm determination sealed inside. Study staff will contact participants to ascertain care status and update contact information at one week, one month, three months, six months, nine months, and twelve months from release. Participants assigned to Full-SPARCS will be asked to attend biweekly sessions. Full-SPARCS activities will include - structured curriculum, symptom screening, and routine laboratory monitoring.
Study sample: A total of 400 participants will be randomized to one of the two arms.
Significance: The proposed study is consistent with NIH HIV/AIDS highest priority research and the South African National Strategic Plan on HIV, Tuberculosis (TB), and Sexually Transmitted Infections (STIs) 2017-2022. The research addresses the HIV/AIDS Research Priority of "retention and engagement in these services, and achievement and maintenance of optimal prevention and treatment responses." It also addresses "health disparities" through a focus on recently released inmates, a marginalized population, and fits with the South African National Strategic Plan prioritizing inmates as a key population for HIV services.
- Conditions
- Retention in Care
- Being tested
- Full-SPARCS Intervention
- Keywords
- Viral Load Suppression, Prison, Transition, Care continuity, HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-SPARCS InterventionBehavioural
Within 14 days of release, participants will have one-on-one contact with a facilitator to update locator information, continue rapport building, review disclosure plans, provide a reminder of SPARCS logistics, and assign or remind the participant to a SPARCS group based on their location of residence and timing of release (depending on whether this occurred pre-release). Each Full-SPARCS meeting lasts approximately 2 hours, and the sessions occur in a private space in a community venue (e.g., community centre or church).
| Study group | Role | What they receive |
|---|---|---|
| Care-as-usual (CAU) arm | No intervention | Per DCS routine, at release, participants will receive a referral letter form the DCS health services and, in most cases, will be provided with a 28-day supply of ART. |
| Full -SPARCS intervention arm | Experimental | The Full-SPARCS component comprises one individual pre-release session, one individual post-release session, and 12 approximately every-other-week (approximately every two weeks) post-release group sessions extending six months post-release. The SPARCS curriculum is designed to build goal setting, prioritizing, and planning skills during the 12 sessions.
During each Full-SPARCS session, participants will work with facilitators to set, review, and update personal goals using standardized goal-setting worksheets. These goal sheets will document participant objectives, action steps, timelines, and progress assessments. Receives: Behavioral: Full-SPARCS Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV RNA (viral load) suppression at 6 months
HIV RNA suppression will be defined as a viral load <1000 copies/mL. Participants without viral load data will be assumed to have a viral load >1000 c/mL.
Measured: 6 months
Secondary outcomes (4)
HIV RNA (viral load) suppression at 12 months
HIV RNA suppression will be defined as a viral load <1000 copies/mL. Participants without viral load data will be assumed to have a viral load >1000 c/mL.
Measured: 12 months
Cost-effectiveness
Cost effectiveness will be measured by combining standardized data collection tools and an analytic framework developed from prior studies to document and classify resources used (e.g. direct human resources, consumables, capital assets) for all intervention-related activities from design, coordination, to direct delivery.
Measured: up to 12 months
Percentage of participants receiving ART at 6 months
Participants receiving ART by 6 months post-release.
Measured: 6 months
Percentage of participants receiving ART at 12 months
Participants receiving ART by 12 months post-release.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start18 Nov 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retention in CareStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is a hybrid type 1 effectiveness-implementation study to compare care as usual with Full-SPARCS. The investigators will recruit participants from correctional facilities in the Department of Correctional Services (DCS) Gauteng Region, South Africa. Study activities for the intervention arm will be delivered in community venues near to where participants live in Tshwane District, Ekurhuleni District, and City of Johannesburg.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Aurum Institute, Seoul National University, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Christopher Hoffmann, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027671
- Sponsor's protocol ID
- IRB00386911
- Acronym
- SPARCS
- Status last verified
- Jun 2026
- First submitted
- 31 Aug 2023
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Peer-delivered Antiretroviral Therapy (ART) and Reentry Community Strategy to Overcome Barriers to HIV Care Continuity During Community Re-entry From Incarceration in South Africa
- ClinicalTrials.gov ID
- NCT06027671
- Acronym / sponsor ID
- SPARCS / IRB00386911
- Conditions
- Retention in Care
- Keywords
- Viral Load Suppression, Prison, Transition, Care continuity, HIV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Aurum Institute, Seoul National University, National Institute of Mental Health (NIMH)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of this study is to implement a transition community adherence club strategy (Full-SPARCS) for HIV-positive individuals transitioning from correctional to community settings in South Africa. The investigators seek to provide actionable findings to inform policy decisions to contribute to HIV care continuity with this population. The investigators note that effectiveness and scalability often conflict with intervention design; thus, the investigators have proposed testing whether a group approach is effective and the investigators will assess the costs of each component
- To compare the effectiveness of Full-SPARCS to care as usual to achieve HIV RNA suppression 6 months following correctional facility release
- To assess determinants of implementation of Full-SPARCS
- To assess the scalability through costing and cost effectiveness analysis of Full-SPARCS
Detailed description
Background: The South African government has devoted resources towards HIV care in correctional facilities that have resulted in antiretroviral therapy (ART) coverage of >90% and viral load (VL) suppression of >80% among incarcerated people living with HIV (PLWH). However, despite free post-release care, the investigators previously observed that only an estimated 34% were in care three months post-release. The investigators developed, tested, and manualized the Structured Peer-delivered ART and Re-entry Community Strategy (SPARCS) to overcome post-incarceration barriers specific to PLWH returning to the community.8-10 In the investigators randomized controlled pilot of SPARCS, 6-month post-release, continuity of care was 61% in the intervention arm compared to 36% in the usual care arm (p=0.001), demonstrating effectiveness. Full-SPARCS involves 12 biweekly peer facilitator-led group sessions spanning six months post-release. Full-SPARCS is designed to increase self-efficacy, social support, and life skills through facilitated group discussion and curriculum including planning, problem solving, financial literacy, and living with HIV.
Methods: This research study will be conducted in Gauteng Province. Recruitment will occur within correctional facilities of the Department of Correctional Services (DCS) - Modderbee, Kgosi Mampuru II, and Johannesburg. All study interventions will occur following release in either Ekurhuleni District, Tshwane District or Johannesburg District. The study population will be comprised of adult (≥18 years old) corrections inmates, either male or female, with known HIV infection and are receiving ART within the correctional facility and are expected to be released back into the community within 3 months of study enrollment Participants will be randomized 1:1 to either the standard of care or Full-SPARCS using sequential envelopes with study arm determination sealed inside. Study staff will contact participants to ascertain care status and update contact information at one week, one month, three months, six months, nine months, and twelve months from release. Participants assigned to Full-SPARCS will be asked to attend biweekly sessions. Full-SPARCS activities will include - structured curriculum, symptom screening, and routine laboratory monitoring.
Study sample: A total of 400 participants will be randomized to one of the two arms.
Significance: The proposed study is consistent with NIH HIV/AIDS highest priority research and the South African National Strategic Plan on HIV, Tuberculosis (TB), and Sexually Transmitted Infections (STIs) 2017-2022. The research addresses the HIV/AIDS Research Priority of "retention and engagement in these services, and achievement and maintenance of optimal prevention and treatment responses." It also addresses "health disparities" through a focus on recently released inmates, a marginalized population, and fits with the South African National Strategic Plan prioritizing inmates as a key population for HIV services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a hybrid type 1 effectiveness-implementation study to compare care as usual with Full-SPARCS. The investigators will recruit participants from correctional facilities in the Department of Correctional Services (DCS) Gauteng Region, South Africa. Study activities for the intervention arm will be delivered in community venues near to where participants live in Tshwane District, Ekurhuleni District, and City of Johannesburg.
| Arm | Type | Receives |
|---|---|---|
| Care-as-usual (CAU) arm | No intervention | –Per DCS routine, at release, participants will receive a referral letter form the DCS health services and, in most cases, will be provided with a 28-day supply of ART. |
| Full -SPARCS intervention arm | Experimental | Behavioral: Full-SPARCS InterventionThe Full-SPARCS component comprises one individual pre-release session, one individual post-release session, and 12 approximately every-other-week (approximately every two weeks) post-release group sessions extending six months post-release. The SPARCS curriculum is designed to build goal setting, prioritizing, and planning skills during the 12 sessions. During each Full-SPARCS session, participants will work with facilitators to set, review, and update personal goals using standardized goal-setting worksheets. These goal sheets will document participant objectives, action steps, timelines, and progress assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Incarcerated at one of the participating study enrolment sites, awaiting trial (un-sentenced) and sentenced individuals.
- Diagnosed with HIV and ART at the time of enrolment.
- Anticipated release or trial date within three months of study enrolment.
- Self-report expected to reside in an unrestricted environment within Ekurhuleni, Tshwane, or Johannesburg districts of Gauteng Province and within proximity to one of the SPARCS intervention sites (i.e., within 20km, 45-minute travel time, or two local taxi minibus rides)
- Willing to participate in study post-release follow-up activities and provide contact information for post-release follow-up.
Key exclusion criteria (6 listed)
- <18 years of age.
- Condition (severe cognitive dysfunction or mental illness) rendering the individual unable to provide informed consent.
- Unable to provide informed consent to participate in the study.
- Assessment by DCS health staff indicating that the individual requires a high intensity of care exceeding that which can be provided in a differentiated model of care setting.
- Not released from the correctional facility during the period of intervention delivery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full-SPARCS InterventionWithin 14 days of release, participants will have one-on-one contact with a facilitator to update locator information, continue rapport building, review disclosure plans, provide a reminder of SPARCS logistics, and assign or remind the participant to a SPARCS group based on their location of residence and timing of release (depending on whether this occurred pre-release). Each Full-SPARCS meeting lasts approximately 2 hours, and the sessions occur in a private space in a community venue (e.g., community centre or church). | Behavioural | Full -SPARCS intervention arm |
Primary outcome
HIV RNA (viral load) suppression at 6 months
Time frame: 6 months
HIV RNA suppression will be defined as a viral load <1000 copies/mL. Participants without viral load data will be assumed to have a viral load >1000 c/mL.
4 secondary outcomes
HIV RNA (viral load) suppression at 12 months
Time frame: 12 months
Cost-effectiveness
Time frame: up to 12 months
Percentage of participants receiving ART at 6 months
Time frame: 6 months
Percentage of participants receiving ART at 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tonderai Mabuto contact
Christopher Hoffmann principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full-SPARCS Intervention in people with Retention in Care, run by Johns Hopkins University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Hoffmann (4106144257, choffmann@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV RNA (viral load) suppression at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.