Clinical trial NCT03286504: FANMI: Community Cohort Care for HIV-Infected Adolescent Girls in Haiti
Official title: FANMI: Community Cohort Care for HIV-Infected Adolescent Girls in Haiti
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-09-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 12 Month Retention
timeFrame: 12 months
Secondary outcomes:
measure: 12 Month Viral Suppression
timeFrame: 12 months
measure: Time to Antiretroviral Therapy (ART) Initiation
timeFrame: 12 months
measure: Optimal Antiretroviral Therapy (ART) Adherence
timeFrame: 12 months
measure: Sexual Risk Behavior
timeFrame: 12 months
measure: Number of Sexually Transmitted Infections
timeFrame: 12 months
measure: Acceptability
timeFrame: 12 months
measure: Healthcare Utilization
timeFrame: 12 months
Other outcomes:
Locations:
city: Port-au-Prince
country: Haiti
facility: GHESKIO
Study officials:
affiliation: Weill Medical College of Cornell University
name: Daniel Fitzgerald, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.