FANMI: Community Cohort Care for HIV-Infected Adolescent Girls in Haiti

NCT ID: NCT03286504

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-25
• Study Completion Date: 2023-10-01

Brief Summary

The investigators will conduct a randomized controlled trial of Group Care in the GHESKIO Community Center versus Individual Care in the GHESKIO Adolescent Clinic for 160 HIV-infected adolescent girls age 16-23 years in Haiti (80 adolescents per arm). Group Care includes receiving integrated clinical and social support services in groups of 5-8 adolescents at a monthly visit. The primary outcome is retention in HIV care at 12 months after randomization.

Detailed Description

The investigators will conduct a randomized controlled trial of Group Care in the GHESKIO Community Center versus Individual Care in the GHESKIO Adolescent Clinic for 160 HIV-infected adolescent girls age 16-23 years in Haiti (80 per arm). Adolescents randomized to Group Care will receive HIV services including integrated clinical and social support care in groups of 5-10. Adolescents randomized to Individual Care will continue to receive individual care at the GHESKIO Adolescent Clinic, which is the current standard of care (described below). If a subject declines to participate in the study they will continue to receive standard HIV care. Participants will be randomized to either Group Care or Individual Care in a 1:1 ratio using a computer generated random assignment.

Individual Care (standard of care): Adolescents randomized to Individual Care will receive care in the GHESKIO Adolescent Clinic which cares for both males and females age 13-23 years. The Adolescent Clinic waiting room has a television showing educational videos. After seeing a triage peer counselor and having their vital signs taken, participants see a nurse practitioner (NP) one-on-one in a private room for a 10-15 minute clinic visit. The NP may also provide family support counseling including family visits per clinical judgment. Each NP sees approximately 20 HIV-infected adolescents per day. The adolescent then returns to the HIV positive peer counselor, who provides one-on-one counseling for 30 minutes on topics chosen by the adolescent and the counselor. Each counselor sees ~10 adolescents per day.

Group Care (intervention): Adolescent girls randomized to Group Care will join a group within one week of study enrollment and receive care in the GHESKIO Community Center. The investigators estimate that it will take 4-6 weeks to constitute a full group of 5-10. During this enrollment phase, groups will meet weekly, adding new participants each week. The participants will then meet monthly with an NP and a HIV positive peer counselor. Each monthly group session will last ~2 hours. This is comparable to the time it takes for a patient to pass through the Adolescent HIV Clinic. It will start with a 30 minute unstructured discussion. This time is intentionally unstructured and responds to our previous research finding that adolescents want to talk about topics of their choosing with their peers. This will be followed by a 45 minute group counseling session following a structured curriculum, addressing topics such as social isolation, stigma, family support, sexual risk behavior, life goals, medication adherence, job skills, and transitions. This is followed by a 30 minute social activity led by two rotating group leaders who are elected by their peers. Social activities include crafts, playing cards, and charades. Participants will be seen one by one by the NP for ~10-15 minutes in a screened in clinical area during the unstructured discussion and the social activity. All HIV clinical services, including provision of antiretroviral therapy (ART) medications, CD4 T cell monitoring, screening for symptoms and OI, medication adherence monitoring, family planning, and general primary care will be provided by the NP. Girls who become eligible for ART will be provided with individual counseling and promptly initiated on ART by the NP. The primary hypothesis is that Group Care will improve retention at 12 months compared with standard Individual Care. The study has > 90% power to detect a difference in retention from 60% to 85%. Participants in both study arms will complete a questionnaire with a research nurse at enrollment, 6, and 12 months collecting data on HIV knowledge, HIV-related stigma, HIV disclosure, social and family support, depression and alcohol use, problem solving skills, and food insecurity.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard-of-care

Adolescents randomized to the standard arm will receive monthly HIV care in the GHESKIO Adolescent Clinic. Clinical care is provided in an individual exam room by a nurse. The patient is sequentially referred to the laboratory, social worker, and pharmacy for medication refills. A typical visit, including wait time, lasts 3 hours.

Group Type: NO_INTERVENTION

No interventions assigned to this group

FANMI - Cohort Care

Adolescents randomized to FANMI will receive all monthly HIV care in the community room of the Prince Albert School in Village of God. Adolescents will be grouped in cohorts of 5-10 peers. The entire visit will take \~ 2 hours.

Group Type: EXPERIMENTAL

FANMI - Cohort Care

Intervention Type: BEHAVIORAL

FANMI includes receiving integrated clinical care, group counseling, and social activities in a single session by the same provider to simplify care and strengthen relationships between peers and providers. FANMI groups consist of 5-10 adolescents meeting once per month.

Interventions

FANMI - Cohort Care

FANMI includes receiving integrated clinical care, group counseling, and social activities in a single session by the same provider to simplify care and strengthen relationships between peers and providers. FANMI groups consist of 5-10 adolescents meeting once per month.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Female
• Age 16-23 years
• ART naive, initiated ART in the past 3 months, or defaulted from care for 3 months or more
• Participant knowledge of HIV-infection
• Willing to receive care at the clinic or in the community
• Willing to provide consent (age 18 -23 years) or assent with parental/guardian consent (16-17 years)

Exclusion Criteria

• Pregnancy at the time of enrollment
• A severe HIV/AIDS illness requiring hospitalization or intensive medical follow-up
• Based on the primary clinician's judgement that the adolescent is at a developmental stage not suited for study participation

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 23 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Fitzgerald, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

GHESKIO

Port-au-Prince, , Haiti

Countries

Haiti

References

Seo G, Joseph JMB, Confident N, Jean E, Louis B, Bell T, Riche RC, Belizaire ME, Rouzier V, Apollon A, Reif L, Rivera V, Abrams E, Bang H, Schackman B, Fitzgerald D, Pape JW, McNairy ML. The FANMI ("my FAMILY" in Creole) study to evaluate community-based cohort care for adolescent and young women living with HIV in Haiti: protocol for a randomized controlled trial. BMC Public Health. 2019 Dec 30;19(1):1749. doi: 10.1186/s12889-019-8065-6.

Reference Type: DERIVED

PMID: 31888569 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01HD091935

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1504016098

Identifier Type: -

Identifier Source: org_study_id