HIVPVNCT07117656
Project Vuselela Feasibility
A study testing Project Vuselela in people with HIV and Drug Users, run by Arizona State University at 1 site in South Africa.
Trial summary
To develop an intervention that engages family members in supporting HIV and opioid substitution therapy treatment for those who inject drugs in South Africa, and then conduct a pilot study to understand feasibility and preliminary impact on outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Drug Users
- What is being tested?
- Project Vuselela
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Africa
- Study dates
- 13 Jul 2025to 28 Aug 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aim 2 PLHWID Inclusion Criteria
- Any sex or gender
- >18 years of age
- HIV-positive as per medical record
- Self-reported injection drug use behavior
- Have not participated in the current ART-OST program
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- Initiating ART or OST
- Identifies a potential family member who can provide support
- Live in Johannesburg
- Family Member Inclusion Criteria
- 18 years of age or older
- Confirms family member (parent, sibling, partner, aunt, uncle, grandparent, cousin)
- Knowledge of the drug using behavior by the PLWHID, but knowledge of their HIV status is not required.
- No recent history of self-reported drug-using behavior (< 5 years)
Who cannot join
- PLHWID Exclusion Criteria
- Under 18 years of age
- HIV-negative as per medical record
- Notself-reported injection drug use behavior
- Has participated in the current ART-OST program
- Taking ART or OST
Show all 13Show fewer
- Cannot identify a potential family member who can provide support
- Does not live in Johannesburg
- Family Member Exclusion Criteria
- Under 18 years of age
- Not a family member
- Does not know about drug using behavior by the PLWHID
- Recent history of self-reported drug-using behavior (< 5 years)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
Anova Health Institute
Johannesburg
Albert Manyuchi, PhD, +27 71 588 5069, manyuchi@anovahealth.co.za
About this study
Official title: Developing and Pilot Testing Project Vuselela for ART and OST Engagement in Johannesburg, South Africa
To develop an intervention that engages family members in supporting HIV and opioid substitution therapy treatment for those who inject drugs in South Africa, and then conduct a pilot study to understand feasibility and preliminary impact on outcomes.
Read the detailed description
In response to increased injection drug use in Johannesburg, South Africa, and low ART and OST treatment retention rates, we will develop and pilot-test the intervention, Project Vuselela. The intervention is designed to engage family members in treatment support using a multi-session skill-building approach that is led by trained peer navigators. Both PLWHIDs and their family members will attend sessions to develop these skills and treatment action plans, facilitated by peer navigators. We will assess PLWHID and family acceptability of the intervention and preliminary impact on PLWHID ART and OST treatment adherence when compared to those in the current program as standard of care. The study will be conducted at Yeoville Clinic in Johannesburg, a setting with high rates of injection drug use and the only OST clinic in the city.
- Conditions
- HIV, Drug Users
- Being tested
- Project Vuselela
- Medical subject headings
- Drug Misuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project VuselelaBehavioural
A four session intervention with people who inject drugs and family members. Delivered three group sessions and one dyad session. Session content designed to improve coping and communication skills that will in turn improve treatment outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Four sessions on coping and communication skills to improve support for treatment among family members and people who inject drugs. Receives: Behavioral: Project Vuselela |
| Standard of Care | No intervention | Offered current harm reduction services at clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the intervention
Assess feasibility, acceptability, willingness and safety. This will be completed using in-depth interviews and a study-specific survey.
Measured: 3 and 6 months
Antiretroviral Therapy Therapy (ART) Adherence
Medical chart review of monthly anti-retroviral therapy (ART) prescription refill data will be collected. ART is medication to manage HIV infection.
Measured: 3 and 6 months
Opioid Substitution Therapy (OST) Adherence
Medical chart review of opioid substitution therapy (OST) pick-up. This measure assesses use of OST to reduce effects of addiction.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start13 Jul 2025
- Primary completion28 Aug 2027 (estimated)
- Study completion28 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- Pilot study to understand intervention feasibility and preliminary impact on HIV and OST outcomes.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117656
- Sponsor's protocol ID
- 11194429
- Other IDs
- R34DA062367
- Acronym
- PV
- Status last verified
- Aug 2025
- First submitted
- 15 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Pilot Testing Project Vuselela for ART and OST Engagement in Johannesburg, South Africa
- ClinicalTrials.gov ID
- NCT07117656
- Acronym / sponsor ID
- PV / 11194429
- Conditions
- HIV, Drug Users
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 13 Jul 2025 (actual)
- Primary completion
- 28 Aug 2027 (estimated)
- Study completion
- 28 Aug 2027 (estimated)
- First posted
- 12 Aug 2025 (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.
To develop an intervention that engages family members in supporting HIV and opioid substitution therapy treatment for those who inject drugs in South Africa, and then conduct a pilot study to understand feasibility and preliminary impact on outcomes.
Detailed description
In response to increased injection drug use in Johannesburg, South Africa, and low ART and OST treatment retention rates, we will develop and pilot-test the intervention, Project Vuselela. The intervention is designed to engage family members in treatment support using a multi-session skill-building approach that is led by trained peer navigators. Both PLWHIDs and their family members will attend sessions to develop these skills and treatment action plans, facilitated by peer navigators. We will assess PLWHID and family acceptability of the intervention and preliminary impact on PLWHID ART and OST treatment adherence when compared to those in the current program as standard of care. The study will be conducted at Yeoville Clinic in Johannesburg, a setting with high rates of injection drug use and the only OST clinic in the city.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot study to understand intervention feasibility and preliminary impact on HIV and OST outcomes.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Project VuselelaFour sessions on coping and communication skills to improve support for treatment among family members and people who inject drugs. |
| Standard of Care | No intervention | –Offered current harm reduction services at clinics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Aim 2 PLHWID Inclusion Criteria
- Any sex or gender
- >18 years of age
- HIV-positive as per medical record
- Self-reported injection drug use behavior
Key exclusion criteria (13 listed)
- PLHWID Exclusion Criteria
- Under 18 years of age
- HIV-negative as per medical record
- Notself-reported injection drug use behavior
- Has participated in the current ART-OST program
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 |
|---|---|---|
| Project VuselelaA four session intervention with people who inject drugs and family members. Delivered three group sessions and one dyad session. Session content designed to improve coping and communication skills that will in turn improve treatment outcomes. | Behavioural | Intervention |
Primary outcome
Feasibility of the intervention
Time frame: 3 and 6 months
Assess feasibility, acceptability, willingness and safety. This will be completed using in-depth interviews and a study-specific survey.
Antiretroviral Therapy Therapy (ART) Adherence
Time frame: 3 and 6 months
Medical chart review of monthly anti-retroviral therapy (ART) prescription refill data will be collected. ART is medication to manage HIV infection.
Opioid Substitution Therapy (OST) Adherence
Time frame: 3 and 6 months
Medical chart review of opioid substitution therapy (OST) pick-up. This measure assesses use of OST to reduce effects of addiction.
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 12 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Vuselela in people with HIV and Drug Users, run by Arizona State 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 14 inclusion and 13 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 12 Aug 2025. 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 Joseph A Daniels, PhD (206 459 5777, Joseph.A.Daniels@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention (time frame: 3 and 6 months). The study lists 3 primary outcomes in all. 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 12 Aug 2025.