Improving Health Outcomes for Women Living With HIV

NCT03525340 | Completed

• 2 other identifiers: 112177R34MH112177
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV/AIDS

Keywords

Engagement to care, peer navigation, transgender

Outcome Measures

Primary Outcomes (1)

• Acceptability of Peer Navigation Intervention

  Proportion of transgender women offered navigation services who accept invitation

  Baseline

Secondary Outcomes (9)

• Feasibility of Peer Navigation Intervention: Patient Satisfaction

  At 9 months

• Feasibility of Peer Navigation Intervention: Enrollment rate

  At 9 months

• Feasibility of Peer Navigation Intervention: Navigator Retention

  At 9 months

• Trial Planning - Linkage to ART

  At 9 months

• Trial Planning - Linkage to confirmatory testing

  At 9 months

Study Arms (2)

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.

Behavioral: Peer Navigation

Interventions

Peer Navigation BEHAVIORAL

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.

Peer Navigation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Assigned male sex at birth, currently identify as female, transgender, transsexual, or travesti (a common term for trans women in Brazil)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Santa Casa Medical School

São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 38481195 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Sheri Lippman, PhD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned 2:1 to intervention group with peer navigation or standard of care

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: May 15, 2018
• Study Start: May 7, 2018
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: November 22, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)