HIV/AIDSNCT03081559
Improving Engagement in HIV Care for High-risk Women
A study testing Healthy Divas in people with HIV/AIDS and Adherence, Medication, run by University of California, San Francisco at 2 sites in United States.
Trial summary
Transgender women (assigned 'male' at birth but who do not identify as male) are disproportionately impacted by HIV and have culturally unique barriers and facilitators to engagement in HIV care. 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
- HIV/AIDS, Adherence, Medication
- What is being tested?
- Healthy Divas
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Nov 2016to 30 Oct 2020
- 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
- 18+ years old; and
- Assigned male sex at birth but does not currently identify as male; and
- English- or Spanish-speaking; and
- HIV+ confirmed via antibody testing; and
- Evidence of suboptimal engagement in HIV care, as indicated by one or more of the following:
- Not on ART; (b) If on ART, reporting less than perfect adherence on a validated adherence rating scale; or (c) Reporting no HIV primary care appointments in the prior 6 months.
Who cannot join
- Evidence of severe cognitive impairment or active psychosis, as determined by the Project Director in consultation with the Principal Investigator.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Friends Community Center
Los Angeles, California, 90028
Alliance Health Project
San Francisco, California, 94103
About this study
Transgender women (assigned 'male' at birth but who do not identify as male) are disproportionately impacted by HIV and have culturally unique barriers and facilitators to engagement in HIV care. Transgender women living with HIV (TWH) are less likely than others to take antiretroviral therapy (ART), and those who initiate ART have lower rates of ART adherence, lower self-efficacy for integrating ART into daily routines, and report fewer positive interactions with health care providers than non-transgender adults. As a result, TWH have an almost three-fold higher viral load than non-transgender adults in San Francisco; in Los Angeles, TWH are less likely to be virally suppressed than any other behavioral risk group. In formative work, the investigators have identified culturally-specific and modifiable barriers to HIV treatment engagement among TWH, including prioritization of transition-related health care (i.e. hormone therapy) at the expense of HIV treatment, avoidance of HIV care settings due to past negative health care experiences, misinformation about ART including potential drug interactions with hormones, intensified HIV stigma, low levels of social support, and poor coping skills. There are both individual and public health consequences to poor engagement in care among TWH stemming from high transmission risk factors, including substance abuse, high numbers of sex partners, engagement in sex work, and high rates of mental illness. These findings strongly suggest that TWH face unique challenges to engaging in and adhering to HIV treatment, and that the public health consequences for poor engagement in this population are of grave concern. Interventions to mitigate these barriers to engagement in care are critical in efforts to alter the pattern of HIV-related disparities that lead to disproportionately poor health outcomes for this highly vulnerable and marginalized population. The investigators are conducting a randomized controlled trial of a theory-driven, population-specific, piloted intervention to improve engagement in care for TWH. Grounded in the investigators' Models of Gender Affirmation and Health Care Empowerment, the proposed research is the first to systematically intervene on complex barriers to optimal engagement in HIV care for TWH. The investigators have developed and piloted the Healthy Divas intervention to optimize engagement in HIV care for TWH at elevated risk for treatment failure and consequential morbidity, mortality, and transmission of HIV.
- Conditions
- HIV/AIDS, Adherence, Medication
- Being tested
- Healthy Divas
- Keywords
- transgender, women
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy DivasBehavioural
Peer-based counseling to improve medication adherence and engagement in care
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Healthy Divas intervention Receives: Behavioral: Healthy Divas |
| Control | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in virologic control
As indicated by an undetectable HIV-1 level on the COBAS® AmpliPrep/COBAS® TaqMan® HIV test kit (Roche Molecular Systems, Inc.)
Measured: Baseline, 3, 6, 9, 12 months
Secondary outcomes (1)
Change in behavioral composite of engagement in HIV care
Composite measure which integrates current/past ART use, HIV appointments timeline followback , ART adherence (adherence rating and visual analog scale), and knowledge of current CD4 cell count.
Measured: Baseline, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start9 Nov 2016
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Friends Research Institute, Inc.
- Responsible party
- Sponsor
- Investigators
- Jae Sevelius, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081559
- Sponsor's protocol ID
- R01MH106373
- Status last verified
- Nov 2020
- First submitted
- 6 Mar 2017
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sevelius J, Veras MASM, Gomez JL, Saggese G, Mocello AR, Bassichetto KC, Neilands TB, Lippman SA. Reducing intersectional stigma among transgender women in Brazil to promote uptake of HIV testing and PrEP: study protocol for a randomised controlled trial of Manas por Manas. BMJ Open. 2024 Jun 21;14(6):e076878. doi: 10.1136/bmjopen-2023-076878.
PubMed 38908840Sevelius JM, Neilands TB, Reback CJ, Castro D, Dilworth SE, Kaplan RL, Johnson MO. An Intervention by and for Transgender Women Living With HIV: Study Protocol for a Two-Arm Randomized Controlled Trial Testing the Efficacy of "Healthy Divas" to Improve HIV Care Outcomes. Front Reprod Health. 2021 Oct 27;3:665723. doi: 10.3389/frph.2021.665723. eCollection 2021.
PubMed 36304034Sevelius JM, Dilworth SE, Reback CJ, Chakravarty D, Castro D, Johnson MO, McCree B, Jackson A, Mata RP, Neilands TB. Randomized Controlled Trial of Healthy Divas: A Gender-Affirming, Peer-Delivered Intervention to Improve HIV Care Engagement Among Transgender Women Living With HIV. J Acquir Immune Defic Syndr. 2022 Aug 15;90(5):508-516. doi: 10.1097/QAI.0000000000003014. Epub 2022 Mar 5.
PubMed 35502891
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Engagement in HIV Care for High-risk Women
- ClinicalTrials.gov ID
- NCT03081559
- Acronym / sponsor ID
- R01MH106373
- Conditions
- HIV/AIDS, Adherence, Medication
- Keywords
- transgender, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Friends Research Institute, Inc.
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 16 Mar 2017 (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.
Transgender women (assigned 'male' at birth but who do not identify as male) are disproportionately impacted by HIV and have culturally unique barriers and facilitators to engagement in HIV care. Transgender women living with HIV (TWH) are less likely than others to take antiretroviral therapy (ART), and those who initiate ART have lower rates of ART adherence, lower self-efficacy for integrating ART into daily routines, and report fewer positive interactions with health care providers than non-transgender adults. As a result, TWH have an almost three-fold higher viral load than non-transgender adults in San Francisco; in Los Angeles, TWH are less likely to be virally suppressed than any other behavioral risk group. In formative work, the investigators have identified culturally-specific and modifiable barriers to HIV treatment engagement among TWH, including prioritization of transition-related health care (i.e. hormone therapy) at the expense of HIV treatment, avoidance of HIV care settings due to past negative health care experiences, misinformation about ART including potential drug interactions with hormones, intensified HIV stigma, low levels of social support, and poor coping skills. There are both individual and public health consequences to poor engagement in care among TWH stemming from high transmission risk factors, including substance abuse, high numbers of sex partners, engagement in sex work, and high rates of mental illness. These findings strongly suggest that TWH face unique challenges to engaging in and adhering to HIV treatment, and that the public health consequences for poor engagement in this population are of grave concern. Interventions to mitigate these barriers to engagement in care are critical in efforts to alter the pattern of HIV-related disparities that lead to disproportionately poor health outcomes for this highly vulnerable and marginalized population. The investigators are conducting a randomized controlled trial of a theory-driven, population-specific, piloted intervention to improve engagement in care for TWH. Grounded in the investigators' Models of Gender Affirmation and Health Care Empowerment, the proposed research is the first to systematically intervene on complex barriers to optimal engagement in HIV care for TWH. The investigators have developed and piloted the Healthy Divas intervention to optimize engagement in HIV care for TWH at elevated risk for treatment failure and consequential morbidity, mortality, and transmission of HIV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Healthy DivasHealthy Divas intervention |
| Control | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18+ years old; and
- Assigned male sex at birth but does not currently identify as male; and
- English- or Spanish-speaking; and
- HIV+ confirmed via antibody testing; and
- Evidence of suboptimal engagement in HIV care, as indicated by one or more of the following:
Key exclusion criteria (1 listed)
- Evidence of severe cognitive impairment or active psychosis, as determined by the Project Director in consultation with the Principal Investigator.
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 |
|---|---|---|
| Healthy DivasPeer-based counseling to improve medication adherence and engagement in care | Behavioural | Intervention |
Primary outcome
Change in virologic control
Time frame: Baseline, 3, 6, 9, 12 months
As indicated by an undetectable HIV-1 level on the COBAS® AmpliPrep/COBAS® TaqMan® HIV test kit (Roche Molecular Systems, Inc.)
1 secondary outcome
Change in behavioral composite of engagement in HIV care
Time frame: Baseline, 3, 6, 9, 12 months
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 16 Nov 2020.
- Derived from this study: PubMed 38908840Sevelius J, Veras MASM, Gomez JL, Saggese G, Mocello AR, Bassichetto KC, Neilands TB, Lippman SA. Reducing intersectional stigma among transgender women in Brazil to promote uptake of HIV testing and PrEP: study protocol for a randomised controlled trial of Manas por Manas. BMJ Open. 2024 Jun 21;14(6):e076878. doi: 10.1136/bmjopen-2023-076878.
- Derived from this study: PubMed 36304034Sevelius JM, Neilands TB, Reback CJ, Castro D, Dilworth SE, Kaplan RL, Johnson MO. An Intervention by and for Transgender Women Living With HIV: Study Protocol for a Two-Arm Randomized Controlled Trial Testing the Efficacy of "Healthy Divas" to Improve HIV Care Outcomes. Front Reprod Health. 2021 Oct 27;3:665723. doi: 10.3389/frph.2021.665723. eCollection 2021.
- Derived from this study: PubMed 35502891Sevelius JM, Dilworth SE, Reback CJ, Chakravarty D, Castro D, Johnson MO, McCree B, Jackson A, Mata RP, Neilands TB. Randomized Controlled Trial of Healthy Divas: A Gender-Affirming, Peer-Delivered Intervention to Improve HIV Care Engagement Among Transgender Women Living With HIV. J Acquir Immune Defic Syndr. 2022 Aug 15;90(5):508-516. doi: 10.1097/QAI.0000000000003014. Epub 2022 Mar 5.
- 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.
Jae Sevelius, PhD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Divas in people with HIV/AIDS and Adherence, Medication, run by University of California, San Francisco 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 6 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: finished, as of the sponsor's last update on 16 Nov 2020. 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. 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?
Change in virologic control (time frame: Baseline, 3, 6, 9, 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 NCT03081559, which also lists 3 linked publications.
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 16 Nov 2020.