Human Immunodeficiency VirusNCT03794245
Bringing South African Men Into HIV Counseling and Testing and Care
A study testing Men-Centered HIV Testing, Linkage to Care for HIV+ Men and Clinic-based HIV Testing in people with Human Immunodeficiency Virus, run by University of California, Los Angeles at 1 site in South Africa.
Trial summary
This clinical trial seeks to determine if male-centered recruitment increases men's testing for HIV and whether or not individualized introduction to clinics increases male engagement in treatment for HIV. The study is being conducted in rural KwaZulu Natal. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Men-Centered HIV Testing, Linkage to Care for HIV+ Men and Clinic-based HIV Testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,806 participants
- Where
- 1 siteSouth Africa
- Study dates
- 7 Jul 2015to 30 Apr 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men residing in the target communities
Who cannot join
- Men outside of the target communities
- Men who report being tested and HIV+
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Human Sciences Research Council
Pietermaritzburg, KwaZulu-Natal
About this study
Official title: Bringing South African Men Into HIV Counseling (HCT) and Care
This clinical trial seeks to determine if male-centered recruitment increases men's testing for HIV and whether or not individualized introduction to clinics increases male engagement in treatment for HIV. The study is being conducted in rural KwaZulu Natal.
Read the detailed description
This study combines structural and individual level interventions for HIV and integrates the two to address the study's objective of identifying South African men in KwaZulu Natal with HIV and maintaining those diagnosed with HIV in care to the point of viral suppression.
The cluster-randomized design will randomize 8 communities to intervention or control to test the hypothesis whether male-centered mobilization and testing increases the population-level percentage of men who have been tested within the past 12 months by more than 10 absolute percentage points.
The individually randomized design will test whether individualized case management will effectively link HIV-positive men to treatment to the point of viral suppression.
The study will also examine the incremental cost-effectiveness of the interventions.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Men-Centered HIV Testing, Linkage to Care for HIV+ Men, Clinic-based HIV Testing, Clinic Referral for HIV+ Men
- Keywords
- Prevention, Testing and Diagnosis, Treatment
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Men-Centered HIV TestingBehavioural
The intervention involves bringing mobile HIV testing to venues where men congregate, talking to them as a group about HIV testing, and then providing testing at that venue.
Linkage to Care for HIV+ MenBehavioural
Men diagnosed with HIV are accompanied to the clinic and registered there with the help of a community health worker.
Clinic-based HIV TestingBehavioural
Individuals present to a clinic and request HIV counseling and testing
Clinic Referral for HIV+ MenBehavioural
Individuals diagnosed with HIV are referred to the nearest clinic for treatment of HIV
| Study group | Role | What they receive |
|---|---|---|
| Men-Centered HIV Testing | Experimental | Mobile HIV testing is conducted at sites in the community where men gather. Receives: Behavioral: Men-Centered HIV Testing |
| Clinic-based HIV Testing | Active comparator | Men are referred to the nearest clinic for HIV counseling and testing Receives: Behavioral: Clinic-based HIV Testing |
| Linkage to Care for HIV+ Men | Experimental | The patient coordinator arranges an appointment time at the clinic and accompanies the patient to the initial visit Receives: Behavioral: Linkage to Care for HIV+ Men |
| Clinic Referral for HIV+ Men | Active comparator | Men diagnosed with HIV are referred to the nearest clinic for treatment of HIV Receives: Behavioral: Clinic Referral for HIV+ Men |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of men tested for HIV
Percentage of men in the community, selected through probability sampling, who report being tested for HIV
Measured: Tested within the past 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start7 Jul 2015
- Primary completion1 Dec 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Men-Centered HIV Testing vs. Clinic-Based HIV Testing; Personalized Linkage to Care for HIV+ Men vs. Clinic Referral for HIV+ Men.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 1,806 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Human Sciences Research Council, Medical University of South Carolina, Charles University, Czech Republic
- Responsible party
- Principal investigator, Thomas J. Coates, University of California, Los Angeles
- Investigators
- THOMAS J COATES, PhD, Principal investigator, University of California, Los AngelesHeidi Van Rooyen, PhD, Principal investigator, Human Sciences Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794245
- Sponsor's protocol ID
- R01MH105534
- Status last verified
- Jul 2023
- First submitted
- 9 Oct 2018
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Rooyen H, Makusha T, Joseph P, Ngubane T, Kulich M, Sweat M, Coates T. Zwakala Ndoda: a cluster and individually randomized trial aimed at improving testing, linkage, and adherence to treatment for hard-to reach men in KwaZulu-Natal, South Africa. Trials. 2019 Dec 30;20(1):798. doi: 10.1186/s13063-019-3908-0.
PubMed 31888701
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bringing South African Men Into HIV Counseling (HCT) and Care
- ClinicalTrials.gov ID
- NCT03794245
- Acronym / sponsor ID
- R01MH105534
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Prevention, Testing and Diagnosis, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,806 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Human Sciences Research Council, Medical University of South Carolina, Charles University, Czech Republic
- Study start
- 7 Jul 2015 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 4 Jan 2019 (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 clinical trial seeks to determine if male-centered recruitment increases men's testing for HIV and whether or not individualized introduction to clinics increases male engagement in treatment for HIV. The study is being conducted in rural KwaZulu Natal.
Detailed description
This study combines structural and individual level interventions for HIV and integrates the two to address the study's objective of identifying South African men in KwaZulu Natal with HIV and maintaining those diagnosed with HIV in care to the point of viral suppression.
The cluster-randomized design will randomize 8 communities to intervention or control to test the hypothesis whether male-centered mobilization and testing increases the population-level percentage of men who have been tested within the past 12 months by more than 10 absolute percentage points.
The individually randomized design will test whether individualized case management will effectively link HIV-positive men to treatment to the point of viral suppression.
The study will also examine the incremental cost-effectiveness of the interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- Men-Centered HIV Testing vs. Clinic-Based HIV Testing; Personalized Linkage to Care for HIV+ Men vs. Clinic Referral for HIV+ Men.
| Arm | Type | Receives |
|---|---|---|
| Men-Centered HIV Testing | Experimental | Behavioral: Men-Centered HIV TestingMobile HIV testing is conducted at sites in the community where men gather. |
| Clinic-based HIV Testing | Active comparator | Behavioral: Clinic-based HIV TestingMen are referred to the nearest clinic for HIV counseling and testing |
| Linkage to Care for HIV+ Men | Experimental | Behavioral: Linkage to Care for HIV+ MenThe patient coordinator arranges an appointment time at the clinic and accompanies the patient to the initial visit |
| Clinic Referral for HIV+ Men | Active comparator | Behavioral: Clinic Referral for HIV+ MenMen diagnosed with HIV are referred to the nearest clinic for treatment of HIV |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men residing in the target communities
Key exclusion criteria (2 listed)
- Men outside of the target communities
- Men who report being tested and HIV+
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 |
|---|---|---|
| Men-Centered HIV TestingThe intervention involves bringing mobile HIV testing to venues where men congregate, talking to them as a group about HIV testing, and then providing testing at that venue. | Behavioural | Men-Centered HIV Testing |
| Linkage to Care for HIV+ MenMen diagnosed with HIV are accompanied to the clinic and registered there with the help of a community health worker. | Behavioural | Linkage to Care for HIV+ Men |
| Clinic-based HIV TestingIndividuals present to a clinic and request HIV counseling and testing | Behavioural | Clinic-based HIV Testing |
| Clinic Referral for HIV+ MenIndividuals diagnosed with HIV are referred to the nearest clinic for treatment of HIV | Behavioural | Clinic Referral for HIV+ Men |
Primary outcome
Percentage of men tested for HIV
Time frame: Tested within the past 12 months
Percentage of men in the community, selected through probability sampling, who report being tested for HIV
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 7 Jul 2023.
- Derived from this study: PubMed 31888701van Rooyen H, Makusha T, Joseph P, Ngubane T, Kulich M, Sweat M, Coates T. Zwakala Ndoda: a cluster and individually randomized trial aimed at improving testing, linkage, and adherence to treatment for hard-to reach men in KwaZulu-Natal, South Africa. Trials. 2019 Dec 30;20(1):798. doi: 10.1186/s13063-019-3908-0.
- 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.
THOMAS J COATES, PhD principal investigator
University of California, Los Angeles
Heidi Van Rooyen, PhD principal investigator
Human Sciences Research Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Men-Centered HIV Testing, Linkage to Care for HIV+ Men and Clinic-based HIV Testing in people with Human Immunodeficiency Virus, run by University of California, Los Angeles 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 1 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 7 Jul 2023. 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?
Percentage of men tested for HIV (time frame: Tested within the past 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03794245, which also lists 1 linked publication.
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 7 Jul 2023.