HivNCT03483857
Peer Navigation to Improve Engagement in Care for HIV-Positive Men Who Have Sex With Men in Ehlanzeni, South Africa
A study testing Peer Navigation in people with Hiv, run by University of California, San Francisco at 1 site in South Africa.
Trial summary
This protocol describes the Cohort Assessment phase of an R34 pilot intervention trial of a Peer Navigation (PN) intervention tailored to the needs of HIV-positive MSM in rural Mpumalanga province South Africa. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hiv
- What is being tested?
- Peer Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteSouth Africa
- Study dates
- 21 Sep 2017to 29 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biological male;
- Age >=18 years;
- Self-identify as a gay or bisexual man, or a transgender woman;
- Have male sexual partners within the prior six months
- Resident in the Ehlanzeni District Municipality for at least six months of the year;
- Be physically present in Ehlanzeni for at least two weeks per month
Show all 10Show fewer
- Self-disclosed receiving an HIV-positive diagnosis in the last 5 years;
- Consent to all serological testing for HIV antibodies, ART analytes, and HIV RNA
- Consent for study staff to review participants' clinical records;
- Consent to the randomization process.
Who cannot join
- Inability to provide written informed consent for participation, including being under the influence of alcohol or drugs.
- Inability to provide laboratory or documentary evidence of HIV diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
This protocol describes the Cohort Assessment phase of an R34 pilot intervention trial of a Peer Navigation (PN) intervention tailored to the needs of HIV-positive MSM in rural Mpumalanga province South Africa. The PN intervention to be adapted, I-Care, has been implemented among HIV-positive men and women in the general population in North West province, South Africa, by members of this research team.
- Conditions
- Hiv
- Being tested
- Peer Navigation
- Keywords
- Peer Navigation
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer NavigationBehavioural
Utilizing Peer Navigators for HIV-Positive MSM for increase in uptake along the continuum.
| Study group | Role | What they receive |
|---|---|---|
| Peer Navigation | Experimental | Individuals assigned to the PN condition will be assigned to one of 10 PN case managers who will follow an SOP described for initial intake and follow up visits with each participant. Participants will be asked to provide contact information for themselves and up to 3 individuals whom study staff can contact in case they cannot make direct contact with the study participant assigned to PN. PN will meet with their clients at least once monthly to discuss treatment related issues including medication access, side effects, adherence, stigma or discrimination related to HIV or their taking ART medication, etc. Participants will have contact information for their assigned PN and may contact them for reasons related to their treatment between scheduled monthly visits if they choose. All visits with PN will be recorded by the PN. and participants who fail to attend up to 3 scheduled PN appointments will be considered LTFU for the intervention. Receives: Behavioral: Peer Navigation |
| Standard of Care | No intervention | Individuals assigned to SOC will be referred directly to the NCHC/RLS staff for treatment initiation or continuation. At intake they will receive standard treatment information per MPDOH guidelines, as well as information about Anova's RLS and Health4Men clinical and psychosocial services available at the NCHC. They will receive monthly text message reminders from study staff to refill ART prescriptions, and a separate reminder in month 6 to schedule complete their 6-month clinical visit. Study staff will verify that participants have picked up medications and attended all scheduled clinical visits by means of chart review and data extraction. Per MPDOH guidelines, individuals who fail to collect medications 3 months in a row, or who fail to attend their 6-month HIV clinical follow-up appointment, will be considered non-engaged and lost to follow up (LTFU). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Suppression
The proportion of participants virally suppressed (HIV RNA <1000 copies/microliter) in Peer Navigation (Intervention) arm compared to standard of care (SOC) arm.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start21 Sep 2017
- Primary completion29 Jun 2018
- Study completion29 Jun 2018
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.
- More trials run by University of California, San FranciscoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm study assessing to determine feasibility and acceptability of a pilot PN intervention among 100 HIV-positive MSM. We will explore associations between PN participation and continuum of care outcomes in a cohort of 55 HIV-positive MSM receiving PN, as compared to a cohort of 48 HIV-positive MSM receiving standard-of-care clinical referral, in preparation for a full-scale multi-site behavioral efficacy trial.
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- ANOVA Health Institute, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Sheri Lippman, PhD, Principal investigator, University of California, San Francsico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483857
- Sponsor's protocol ID
- 1R34MH109395-01
- Status last verified
- Feb 2020
- First submitted
- 24 Oct 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Navigation to Improve Engagement in Care for HIV-Positive Men Who Have Sex With Men in Ehlanzeni, South Africa
- ClinicalTrials.gov ID
- NCT03483857
- Acronym / sponsor ID
- 1R34MH109395-01
- Conditions
- Hiv
- Keywords
- Peer Navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- ANOVA Health Institute, National Institutes of Health (NIH)
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 30 Mar 2018 (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.
This protocol describes the Cohort Assessment phase of an R34 pilot intervention trial of a Peer Navigation (PN) intervention tailored to the needs of HIV-positive MSM in rural Mpumalanga province South Africa. The PN intervention to be adapted, I-Care, has been implemented among HIV-positive men and women in the general population in North West province, South Africa, by members of this research team.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arm study assessing to determine feasibility and acceptability of a pilot PN intervention among 100 HIV-positive MSM. We will explore associations between PN participation and continuum of care outcomes in a cohort of 55 HIV-positive MSM receiving PN, as compared to a cohort of 48 HIV-positive MSM receiving standard-of-care clinical referral, in preparation for a full-scale multi-site behavioral efficacy trial.
| Arm | Type | Receives |
|---|---|---|
| Peer Navigation | Experimental | Behavioral: Peer NavigationIndividuals assigned to the PN condition will be assigned to one of 10 PN case managers who will follow an SOP described for initial intake and follow up visits with each participant. Participants will be asked to provide contact information for themselves and up to 3 individuals whom study staff can contact in case they cannot make direct contact with the study participant assigned to PN. PN will meet with their clients at least once monthly to discuss treatment related issues including medication access, side effects, adherence, stigma or discrimination related to HIV or their taking ART medication, etc. Participants will have contact information for their assigned PN and may contact them for reasons related to their treatment between scheduled monthly visits if they choose. All visits with PN will be recorded by the PN. and participants who fail to attend up to 3 scheduled PN appointments will be considered LTFU for the intervention. |
| Standard of Care | No intervention | –Individuals assigned to SOC will be referred directly to the NCHC/RLS staff for treatment initiation or continuation. At intake they will receive standard treatment information per MPDOH guidelines, as well as information about Anova's RLS and Health4Men clinical and psychosocial services available at the NCHC. They will receive monthly text message reminders from study staff to refill ART prescriptions, and a separate reminder in month 6 to schedule complete their 6-month clinical visit. Study staff will verify that participants have picked up medications and attended all scheduled clinical visits by means of chart review and data extraction. Per MPDOH guidelines, individuals who fail to collect medications 3 months in a row, or who fail to attend their 6-month HIV clinical follow-up appointment, will be considered non-engaged and lost to follow up (LTFU). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Biological male;
- Age >=18 years;
- Self-identify as a gay or bisexual man, or a transgender woman;
- Have male sexual partners within the prior six months
- Resident in the Ehlanzeni District Municipality for at least six months of the year;
Key exclusion criteria (2 listed)
- Inability to provide written informed consent for participation, including being under the influence of alcohol or drugs.
- Inability to provide laboratory or documentary evidence of HIV diagnosis.
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 |
|---|---|---|
| Peer NavigationUtilizing Peer Navigators for HIV-Positive MSM for increase in uptake along the continuum. | Behavioural | Peer Navigation |
Primary outcome
Viral Suppression
Time frame: 6 months
The proportion of participants virally suppressed (HIV RNA <1000 copies/microliter) in Peer Navigation (Intervention) arm compared to standard of care (SOC) arm.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sheri Lippman, PhD principal investigator
University of California, San Francsico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Navigation in people with Hiv, run by University of California, San Francisco 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 10 inclusion and 2 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: finished, as of the sponsor's last update on 5 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Suppression (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 5 Feb 2020.