HIV I InfectionYomelelaNCT05110963
Intervention to Improve HIV Care Retention by Addressing Stigma Stigmatized Environments
A study testing Behavioral Self-Regulation Skills Counseling and Behavioral Self-Regulation Skills Counseling + Stigma Management in people with HIV I Infection, run by University of Connecticut at 2 sites in United States.
Trial summary
Retention in care and persistent adherence to antiretroviral therapy are necessary for the successful treatment of HIV infection. HIV-related stigma is a known impediment to the care and health outcomes of people living with HIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV I Infection
- What is being tested?
- Behavioral Self-Regulation Skills Counseling and Behavioral Self-Regulation Skills Counseling + Stigma Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,771 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2021to 1 Nov 2026
- 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
- 18 years of age or older
- current clinic visit to receive cART in differentiated care outside of an adherence club
- unsuppressed HIV at the most recent clinical testing confirmed in run-in
- access to a phone
Who cannot join
- Not meeting inclusion
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Connecticut Field Site
Atlanta, Georgia, 30308
University of Connecticut
Storrs, Connecticut, 06269
About this study
Official title: Intervention to Improve HIV Care Retention and Antiretroviral Adherence in Stigmatized Environments
Retention in care and persistent adherence to antiretroviral therapy are necessary for the successful treatment of HIV infection. HIV-related stigma is a known impediment to the care and health outcomes of people living with HIV. The proposed study will test theory-based interventions designed to manage HIV stigma in order to improve care retention and medication adherence in communities with high-levels of HIV-related stigma.
Read the detailed description
This trial is conducting a randomized test of a behavioral self-management intervention designed to improve HIV treatment outcomes in people living with HIV in stigmatized contexts. The trial includes a control arm and a non-stigma enhanced treatment adherence intervention arm. Participants living in an economically under-resourced area of South Africa are recruited through clinical care settings. The goal of the research is to examine whether directly addressing HIV stigma and medication adherence management improves treatment outcomes beyond those observed from a standard behavioral intervention without added stigma-addressing components.
- Conditions
- HIV I Infection
- Being tested
- Uniform Standard of Care Counseling, Behavioral Self-Regulation Skills Counseling, Behavioral Self-Regulation Skills Counseling + Stigma Management
- Keywords
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uniform Standard of Care CounselingBehavioural
Routine HIV counseling services available to patients with protocol delivered services. Three sessions of patient education monitored for protocol adherence
Behavioral Self-Regulation Skills CounselingBehavioural
Mobile phone-delivered counseling grounded in Behavioral Self- Regulation Theory to improve retention in HIV care and HIV viral suppression. Counseling is delivered by lay counselors in differentiated health care context. This is a culturally tailored adaptation of CDC disseminated Phone-Delivered Support Counseling for HIV treatment Adherence.
Behavioral Self-Regulation Skills Counseling + Stigma ManagementBehavioural
Mobile phone-delivered counseling grounded in Behavioral Self- Regulation Theory with stigma management to improve retention in HIV care and HIV viral suppression. Counseling is delivered by lay counselors in differentiated health care context with added components directly targeting stigma-related experiences and concerns.
| Study group | Role | What they receive |
|---|---|---|
| Uniform Standard of Care Counseling | Placebo comparator | Routine HIV counseling services available to patients with protocol delivered services. Three sessions of patient education monitored for protocol adherence. Receives: Behavioral: Uniform Standard of Care Counseling |
| Behavioral Self-Regulation Skills Counseling | Active comparator | Mobile phone-delivered counseling grounded in Behavioral Self- Regulation Theory to improve retention in HIV care and HIV viral suppression. Counseling is delivered by lay counselors in differentiated health care context. This is a culturally tailored adaptation of CDC disseminated Phone-Delivered Support Counseling for HIV treatment Adherence. Receives: Behavioral: Behavioral Self-Regulation Skills Counseling |
| Behavioral Self-Regulation Skills Counseling + Stigma Management | Experimental | Mobile phone-delivered counseling grounded in Behavioral Self- Regulation Theory with stigma management to improve retention in HIV care and HIV viral suppression. Counseling is delivered by lay counselors in differentiated health care context with added components directly targeting stigma-related experiences and concerns. Receives: Behavioral: Behavioral Self-Regulation Skills Counseling + Stigma Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Records of Care Appointments
Medical records are retrospectively collected for all scheduled care visits and coded for whether the visits were attended.The records are exclusively from the clinic where patients are initially recruited and with patient permission. The data obtained are expressed as the ratio of the number of care appointments attended relative to the number scheduled.
Measured: 12-months
Blood Plasma RNA
Collection of dried blood spots are tested for HIV RNA (viral load) using PCR tests with results expressed as the number of RNA copies per mL of blood plasma.
Measured: 12-months
Secondary outcomes (1)
Antiretroviral Medication Adherence
Monthly unannounced phone assessments are used to conduct pill counts of antiretroviral medications. The pill counts are used to calculate the proportion of pills taken relative to the number of pills prescribed over a 30 day period.
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 posted8 Nov 2021
- Study start1 Feb 2021
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
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 HIV I InfectionStudies 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
- Behavioral skills training to improve medication adherence
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,771 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South Africa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110963
- Sponsor's protocol ID
- H19-157
- Acronym
- Yomelela
- Status last verified
- Aug 2025
- First submitted
- 15 Oct 2021
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalichman SC, Mathews C, Banas E, Kalichman MO. Stigma management intervention to improve antiretroviral therapy adherence: Phase-I test of concept trial, Cape Town South Africa. Glob Public Health. 2019 Aug;14(8):1059-1074. doi: 10.1080/17441692.2018.1552307. Epub 2018 Nov 30.
PubMed 30500309
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Improve HIV Care Retention and Antiretroviral Adherence in Stigmatized Environments
- ClinicalTrials.gov ID
- NCT05110963
- Acronym / sponsor ID
- Yomelela / H19-157
- Conditions
- HIV I Infection
- Keywords
- HIV
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,771 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- Medical Research Council, South Africa
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 8 Nov 2021 (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.
Retention in care and persistent adherence to antiretroviral therapy are necessary for the successful treatment of HIV infection. HIV-related stigma is a known impediment to the care and health outcomes of people living with HIV. The proposed study will test theory-based interventions designed to manage HIV stigma in order to improve care retention and medication adherence in communities with high-levels of HIV-related stigma.
Detailed description
This trial is conducting a randomized test of a behavioral self-management intervention designed to improve HIV treatment outcomes in people living with HIV in stigmatized contexts. The trial includes a control arm and a non-stigma enhanced treatment adherence intervention arm. Participants living in an economically under-resourced area of South Africa are recruited through clinical care settings. The goal of the research is to examine whether directly addressing HIV stigma and medication adherence management improves treatment outcomes beyond those observed from a standard behavioral intervention without added stigma-addressing components.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Behavioral skills training to improve medication adherence
| Arm | Type | Receives |
|---|---|---|
| Uniform Standard of Care Counseling | Placebo comparator | Behavioral: Uniform Standard of Care CounselingRoutine HIV counseling services available to patients with protocol delivered services. Three sessions of patient education monitored for protocol adherence. |
| Behavioral Self-Regulation Skills Counseling | Active comparator | Behavioral: Behavioral Self-Regulation Skills CounselingMobile phone-delivered counseling grounded in Behavioral Self- Regulation Theory to improve retention in HIV care and HIV viral suppression. Counseling is delivered by lay counselors in differentiated health care context. This is a culturally tailored adaptation of CDC disseminated Phone-Delivered Support Counseling for HIV treatment Adherence. |
| Behavioral Self-Regulation Skills Counseling + Stigma Management | Experimental | Behavioral: Behavioral Self-Regulation Skills Counseling + Stigma ManagementMobile phone-delivered counseling grounded in Behavioral Self- Regulation Theory with stigma management to improve retention in HIV care and HIV viral suppression. Counseling is delivered by lay counselors in differentiated health care context with added components directly targeting stigma-related experiences and concerns. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- current clinic visit to receive cART in differentiated care outside of an adherence club
- unsuppressed HIV at the most recent clinical testing confirmed in run-in
- access to a phone
Key exclusion criteria (1 listed)
- Not meeting inclusion
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 |
|---|---|---|
| Uniform Standard of Care CounselingRoutine HIV counseling services available to patients with protocol delivered services. Three sessions of patient education monitored for protocol adherence | Behavioural | Uniform Standard of Care Counseling |
| Behavioral Self-Regulation Skills CounselingMobile phone-delivered counseling grounded in Behavioral Self- Regulation Theory to improve retention in HIV care and HIV viral suppression. Counseling is delivered by lay counselors in differentiated health care context. This is a culturally tailored adaptation of CDC disseminated Phone-Delivered Support Counseling for HIV treatment Adherence. | Behavioural | Behavioral Self-Regulation Skills Counseling |
| Behavioral Self-Regulation Skills Counseling + Stigma ManagementMobile phone-delivered counseling grounded in Behavioral Self- Regulation Theory with stigma management to improve retention in HIV care and HIV viral suppression. Counseling is delivered by lay counselors in differentiated health care context with added components directly targeting stigma-related experiences and concerns. | Behavioural | Behavioral Self-Regulation Skills Counseling + Stigma Management |
Primary outcome
Medical Records of Care Appointments
Time frame: 12-months
Medical records are retrospectively collected for all scheduled care visits and coded for whether the visits were attended.The records are exclusively from the clinic where patients are initially recruited and with patient permission. The data obtained are expressed as the ratio of the number of care appointments attended relative to the number scheduled.
Blood Plasma RNA
Time frame: 12-months
Collection of dried blood spots are tested for HIV RNA (viral load) using PCR tests with results expressed as the number of RNA copies per mL of blood plasma.
1 secondary outcome
Antiretroviral Medication Adherence
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 29 Aug 2025.
- Background: PubMed 30500309Kalichman SC, Mathews C, Banas E, Kalichman MO. Stigma management intervention to improve antiretroviral therapy adherence: Phase-I test of concept trial, Cape Town South Africa. Glob Public Health. 2019 Aug;14(8):1059-1074. doi: 10.1080/17441692.2018.1552307. Epub 2018 Nov 30.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Self-Regulation Skills Counseling and Behavioral Self-Regulation Skills Counseling + Stigma Management in people with HIV I Infection, run by University of Connecticut at 2 sites in United States.
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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 29 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 2 sites in United States. 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. Some participants in this study may receive a placebo. 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?
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?
Medical Records of Care Appointments (time frame: 12-months). The study lists 2 primary outcomes in all. 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 NCT05110963, 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 29 Aug 2025.