HIV/AIDSNCT03525340
Improving Health Outcomes for Women Living With HIV
A study testing Peer Navigation in people with HIV/AIDS, run by University of California, San Francisco at 1 site in Brazil.
Trial summary
This study will develop and conduct a trans-specific peer navigation intervention in Brazil, which integrates the I-Care approach developed in South Africa with the Model of Gender Affirmation (GA), developed by the investigators to specifically address HIV prevention and care among trans women. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV/AIDS
- 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
- 113 participants
- Where
- 1 siteBrazil
- Study dates
- 7 May 2018to 15 Oct 2019
- 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
- have either a recent HIV diagnosis (within the prior 12 months) or be out of care for previously diagnosed HIV
- be a resident of the São Paulo area
- consent for study staff to review their clinical records
Who cannot join
- female sex at birth
- less than 18 years of age
- not HIV-positive
- currently engaged in care
- unable to provide informed consent
- reside outside of the São Paulo area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Health Outcomes for HIV-Positive Women in Brazil
This study will develop and conduct a trans-specific peer navigation intervention in Brazil, which integrates the I-Care approach developed in South Africa with the Model of Gender Affirmation (GA), developed by the investigators to specifically address HIV prevention and care among trans women.
Read the detailed description
Globally, transgender ('trans') women have 49 times higher odds of HIV infection compared to other groups and trans women living with HIV (TWH) access HIV care and adhere to medication at significantly lower rates than other at-risk groups. Poor engagement in HIV care for TWH is a result of reduced access to and avoidance of healthcare due to stigma and negative experiences with providers, and occurs in the context of social and economic marginalization that foments unstable employment and housing, familial alienation, limited social support, and substance abuse. Interventions to mitigate these barriers to care are critical to reducing HIV-related disparities and poor health outcomes for this highly vulnerable population, particularly where disparities are most apparent, including Brazil. Peer-based navigation (PN) interventions have demonstrated success in improving engagement in HIV care in low-resource settings. The investigators recently conducted a PN intervention ('I-Care') in rural South Africa that significantly improved both linkage to care and retention for men and women. While the PN intervention addresses HIV care engagement by providing social support and skills to work with health providers and family, it requires specific adaptation and a conceptual model that addresses the unique needs of TWH identified during formative research and in consultations with Brazilian stakeholders in 2015. The investigators propose to develop and conduct a trans-specific PN intervention in Brazil, tentatively named 'TransAmigas', which integrates the I-Care approach with the Model of Gender Affirmation (GA), developed by the research team to specifically address HIV prevention and care among trans women. The investigators will use the ADAPT-ITT methodology to develop TransAmigas, incorporating the GA model in the Brazilian context (Aim 1). The investigators will then conduct a pilot study to test the feasibility and acceptability of TransAmigas in São Paulo, Brazil (Aim 2) by randomizing TWH to the intervention (n=100) or to clinical referral (n=50). During the nine month pilot, the investigators will track both navigator and patient adherence to the program, recruitment needs, cohort retention, and reported satisfaction and preferences for program content through surveys at baseline and nine months. Finally, the investigators will prepare for a multi-site efficacy trial (Aim 3) by extracting clinical data from participants' records at the referral clinic, generating preliminary efficacy data by comparing retention in HIV care and viral load by intervention arm. Clinical data will inform future trial sample size. The study will be implemented in Sao Paulo, Brazil, where universal access to care and public support for gender transition care provide an enabling environment for this work to be most effective and where the team has established academic partnerships and a collaboration with the State-run reference and training clinical site (CRT), which includes trans-specific clinical services. If feasible, acceptable, and ultimately proven efficacious, TransAmigas will be the first evidence-based HIV care intervention for TWH globally - filling a crucial gap in programming.
- Conditions
- HIV/AIDS
- Being tested
- Peer Navigation
- Keywords
- Engagement to care, peer navigation, transgender
- 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
Peer navigators help participants identify barriers that pose challenges to the participant's engagement in care and adherence and help develop an overall action plan for addressing these barriers by identifying specific changes that can be made/attempted to overcome an identified barrier. This may involve accompanying a participant to their social services/health appointments, or assisting a participant with disclosure of her HIV status to a family member or friend. The overall goal is to develop knowledge of social/HIV-related health services and good problem-solving skills in order to tackle multiple, potentially overlapping barriers. Over time, participants are encouraged to take increasing degrees of responsibility for identifying and implementing their own problem-solving strategies.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Participants in the standard of care arm will receive no navigation assistance to remain in care. They will provide informed consent, respond to baseline and endline surveys, and have clinic record data extracted for the 9 months of their study participation, but no additional services to remain engaged in care other than what is provided as standard by the clinic. |
| Peer Navigation | Experimental | Participants in the peer navigation arm will meet with a peer navigator at least once per month for nine months in-person, and have at least one other navigator contact per month. Like the standard of care arm, they will provide informed consent, respond to baseline and endline surveys, and have clinic record data extracted for the 9 months of their study participation. Receives: Behavioral: Peer Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Peer Navigation Intervention
Proportion of transgender women offered navigation services who accept invitation
Measured: Baseline
Secondary outcomes (9)
Feasibility of Peer Navigation Intervention: Patient Satisfaction
Proportion in TransAmigas who report satisfaction with navigation quality, duration, contact schedule, thematic content, support.
Measured: At 9 months
Feasibility of Peer Navigation Intervention: Enrollment rate
Proportion of transgender women living with HIV who are screened, eligible, enrolled, and successfully complete navigation.
Measured: At 9 months
Feasibility of Peer Navigation Intervention: Navigator Retention
Proportion of navigators who remain in program.
Measured: At 9 months
Trial Planning - Linkage to ART
Time from diagnosis to antiretroviral therapy initiation
Measured: At 9 months
Trial Planning - Linkage to confirmatory testing
Time from diagnosis to CD4+ T-cell count results
Measured: At 9 months
Trial Planning - Retention
Proportion of patients who remain on treatment following 9 months of enrollment in pilot
Measured: At 9 months
Trial Planning - Defaulting
Proportion of participants not in care 90 days after prescribed medication estimated to last 90
Measured: At 9 months
Trial Planning - Adherence
Proportion of days covered (# of dispensed days of medication / # of days between refills)
Measured: At 9 months
Trial Planning - Viral Suppression
Proportion of participants with viral load 1) undetectable and 2) below 1000 copies/mL
Measured: At 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start7 May 2018
- Primary completion15 Oct 2019
- Study completion15 Oct 2019
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/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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned 2:1 to intervention group with peer navigation or standard of care
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sheri Lippman, PhD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525340
- Sponsor's protocol ID
- 112177
- Other IDs
- R34MH112177
- Status last verified
- Nov 2019
- First submitted
- 28 Feb 2018
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Sousa Mascena Veras MA, Menezes NP, Mocello AR, Leddy AM, Saggese GSR, Bassichetto KC, Gilmore HJ, de Carvalho PGC, Maschiao LF, Neilands TB, Sevelius J, Lippman SA. Correlation between gender-based violence and poor treatment outcomes among transgender women living with HIV in Brazil. BMC Public Health. 2024 Mar 13;24(1):791. doi: 10.1186/s12889-024-18224-3.
PubMed 38481195
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health Outcomes for HIV-Positive Women in Brazil
- ClinicalTrials.gov ID
- NCT03525340
- Acronym / sponsor ID
- 112177
- Conditions
- HIV/AIDS
- Keywords
- Engagement to care, peer navigation, transgender
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 7 May 2018 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 15 May 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 study will develop and conduct a trans-specific peer navigation intervention in Brazil, which integrates the I-Care approach developed in South Africa with the Model of Gender Affirmation (GA), developed by the investigators to specifically address HIV prevention and care among trans women.
Detailed description
Globally, transgender ('trans') women have 49 times higher odds of HIV infection compared to other groups and trans women living with HIV (TWH) access HIV care and adhere to medication at significantly lower rates than other at-risk groups. Poor engagement in HIV care for TWH is a result of reduced access to and avoidance of healthcare due to stigma and negative experiences with providers, and occurs in the context of social and economic marginalization that foments unstable employment and housing, familial alienation, limited social support, and substance abuse. Interventions to mitigate these barriers to care are critical to reducing HIV-related disparities and poor health outcomes for this highly vulnerable population, particularly where disparities are most apparent, including Brazil. Peer-based navigation (PN) interventions have demonstrated success in improving engagement in HIV care in low-resource settings. The investigators recently conducted a PN intervention ('I-Care') in rural South Africa that significantly improved both linkage to care and retention for men and women. While the PN intervention addresses HIV care engagement by providing social support and skills to work with health providers and family, it requires specific adaptation and a conceptual model that addresses the unique needs of TWH identified during formative research and in consultations with Brazilian stakeholders in 2015. The investigators propose to develop and conduct a trans-specific PN intervention in Brazil, tentatively named 'TransAmigas', which integrates the I-Care approach with the Model of Gender Affirmation (GA), developed by the research team to specifically address HIV prevention and care among trans women. The investigators will use the ADAPT-ITT methodology to develop TransAmigas, incorporating the GA model in the Brazilian context (Aim 1). The investigators will then conduct a pilot study to test the feasibility and acceptability of TransAmigas in São Paulo, Brazil (Aim 2) by randomizing TWH to the intervention (n=100) or to clinical referral (n=50). During the nine month pilot, the investigators will track both navigator and patient adherence to the program, recruitment needs, cohort retention, and reported satisfaction and preferences for program content through surveys at baseline and nine months. Finally, the investigators will prepare for a multi-site efficacy trial (Aim 3) by extracting clinical data from participants' records at the referral clinic, generating preliminary efficacy data by comparing retention in HIV care and viral load by intervention arm. Clinical data will inform future trial sample size. The study will be implemented in Sao Paulo, Brazil, where universal access to care and public support for gender transition care provide an enabling environment for this work to be most effective and where the team has established academic partnerships and a collaboration with the State-run reference and training clinical site (CRT), which includes trans-specific clinical services. If feasible, acceptable, and ultimately proven efficacious, TransAmigas will be the first evidence-based HIV care intervention for TWH globally - filling a crucial gap in programming.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned 2:1 to intervention group with peer navigation or standard of care
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Participants in the standard of care arm will receive no navigation assistance to remain in care. They will provide informed consent, respond to baseline and endline surveys, and have clinic record data extracted for the 9 months of their study participation, but no additional services to remain engaged in care other than what is provided as standard by the clinic. |
| Peer Navigation | Experimental | Behavioral: Peer NavigationParticipants in the peer navigation arm will meet with a peer navigator at least once per month for nine months in-person, and have at least one other navigator contact per month. Like the standard of care arm, they will provide informed consent, respond to baseline and endline surveys, and have clinic record data extracted for the 9 months of their study participation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- have either a recent HIV diagnosis (within the prior 12 months) or be out of care for previously diagnosed HIV
- be a resident of the São Paulo area
- consent for study staff to review their clinical records
Key exclusion criteria (6 listed)
- female sex at birth
- less than 18 years of age
- not HIV-positive
- currently engaged in care
- unable to provide informed consent
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 NavigationPeer navigators help participants identify barriers that pose challenges to the participant's engagement in care and adherence and help develop an overall action plan for addressing these barriers by identifying specific changes that can be made/attempted to overcome an identified barrier. This may involve accompanying a participant to their social services/health appointments, or assisting a participant with disclosure of her HIV status to a family member or friend. The overall goal is to develop knowledge of social/HIV-related health services and good problem-solving skills in order to tackle multiple, potentially overlapping barriers. Over time, participants are encouraged to take increasing degrees of responsibility for identifying and implementing their own problem-solving strategies. | Behavioural | Peer Navigation |
Primary outcome
Acceptability of Peer Navigation Intervention
Time frame: Baseline
Proportion of transgender women offered navigation services who accept invitation
9 secondary outcomes
Feasibility of Peer Navigation Intervention: Patient Satisfaction
Time frame: At 9 months
Feasibility of Peer Navigation Intervention: Enrollment rate
Time frame: At 9 months
Feasibility of Peer Navigation Intervention: Navigator Retention
Time frame: At 9 months
Trial Planning - Linkage to ART
Time frame: At 9 months
Trial Planning - Linkage to confirmatory testing
Time frame: At 9 months
Trial Planning - Retention
Time frame: At 9 months
Trial Planning - Defaulting
Time frame: At 9 months
Trial Planning - Adherence
Time frame: At 9 months
Trial Planning - Viral Suppression
Time frame: At 9 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 22 Nov 2019.
- Derived from this study: PubMed 38481195de Sousa Mascena Veras MA, Menezes NP, Mocello AR, Leddy AM, Saggese GSR, Bassichetto KC, Gilmore HJ, de Carvalho PGC, Maschiao LF, Neilands TB, Sevelius J, Lippman SA. Correlation between gender-based violence and poor treatment outcomes among transgender women living with HIV in Brazil. BMC Public Health. 2024 Mar 13;24(1):791. doi: 10.1186/s12889-024-18224-3.
- 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, MPH principal investigator
University of California, San Francisco
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/AIDS, run by University of California, San Francisco at 1 site in Brazil.
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 3 inclusion and 6 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 22 Nov 2019. 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 Brazil. 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?
Acceptability of Peer Navigation Intervention (time frame: Baseline). 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 NCT03525340, 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 22 Nov 2019.