Improving Health Outcomes for Women Living With HIV
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|ClinicalTrials.gov Identifier: NCT03525340|
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Behavioral: Peer Navigation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomly assigned 2:1 to intervention group with peer navigation or standard of care|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Improving Health Outcomes for HIV-Positive Women in Brazil|
|Actual Study Start Date :||May 7, 2018|
|Estimated Primary Completion Date :||May 30, 2019|
|Estimated Study Completion Date :||July 30, 2019|
No Intervention: Standard of Care
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.
Experimental: Peer Navigation
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
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.
- Acceptability of Peer Navigation Intervention [ Time Frame: Baseline ]Proportion of transgender women offered navigation services who accept invitation
- Feasibility of Peer Navigation Intervention: Patient Satisfaction [ Time Frame: At 9 months ]Proportion in TransAmigas who report satisfaction with navigation quality, duration, contact schedule, thematic content, support.
- Feasibility of Peer Navigation Intervention: Enrollment rate [ Time Frame: At 9 months ]Proportion of transgender women living with HIV who are screened, eligible, enrolled, and successfully complete navigation.
- Feasibility of Peer Navigation Intervention: Navigator Retention [ Time Frame: At 9 months ]Proportion of navigators who remain in program.
- Trial Planning - Linkage to ART [ Time Frame: At 9 months ]Time from diagnosis to antiretroviral therapy initiation
- Trial Planning - Linkage to confirmatory testing [ Time Frame: At 9 months ]Time from diagnosis to CD4+ T-cell count results
- Trial Planning - Retention [ Time Frame: At 9 months ]Proportion of patients who remain on treatment following 9 months of enrollment in pilot
- Trial Planning - Defaulting [ Time Frame: At 9 months ]Proportion of participants not in care 90 days after prescribed medication estimated to last 90
- Trial Planning - Adherence [ Time Frame: At 9 months ]Proportion of days covered (# of dispensed days of medication / # of days between refills)
- Trial Planning - Viral Suppression [ Time Frame: At 9 months ]Proportion of participants with viral load 1) undetectable and 2) below 1000 copies/mL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525340
|Contact: Sheri Lippman, PhD, MPH||415-502-1000 ext firstname.lastname@example.org|
|Contact: Jae Sevelius, PhD||415-502-1000 ext email@example.com|
|Santa Casa Medical School||Recruiting|
|São Paulo, Brazil|
|Contact: Daniel Barros (11) 3367-7858|
|Principal Investigator: Maria Amelia Veras, MD|
|Sub-Investigator: Gustavo Saggese, PhD|
|Principal Investigator:||Sheri Lippman, PhD, MPH||University of California, San Francisco|