ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03286504
Recruitment Status : Recruiting
First Posted : September 18, 2017
Last Update Posted : June 4, 2018
Sponsor:
Collaborator:
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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 16-19 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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: FANMI - Cohort Care Not Applicable

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 16-19 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 5-8. 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 13-19 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 5-8. 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 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, 3, 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FANMI: Community Cohort Care for HIV-Infected Adolescent Girls in Haiti
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: 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.
Experimental: 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 5-8 peers. The entire visit will take ~ 2 hours.
Behavioral: 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 5-8 adolescents meeting once per month.




Primary Outcome Measures :
  1. 12 month retention [ Time Frame: 12 months ]
    Retention in care at 12 months will be measured. 12 month retention is defined as being alive at 12 months and having a care visit between 11 and 13 months after enrollment.


Secondary Outcome Measures :
  1. 12 month viral suppression [ Time Frame: 12 months ]
    Viral suppression at 12 months will be measured. Suppressed viral load will be defined as a binary outcome based upon the WHO definition of viral suppression as a plasma HIV-1 RNA level <1000 copies/µl.

  2. Time to ART initation [ Time Frame: 12 months ]
    Time to ART initiation is the number of calendar days from date of HIV diagnosis to date of ART initiation.

  3. ART adherence [ Time Frame: 12 months ]
    ART adherence will be measured by 3-day recall at the 3, 6 and 12 month study visits and a tenofovir diphosphate (TFV-DP) level in a dried blood spot collected at 3, 6 and 12 months by the research nurse.

  4. Sexual risk behavior [ Time Frame: 12 months ]
    Sexual risk behavior will be measured by the Adolescent Sexual Activity Index (ASAI) at enrollment, 3, 6 and 12 months by a research nurse. We will also document condom use.

  5. Sexually transmitted infections [ Time Frame: 12 months ]
    Sexually Transmitted Infections will be evaluated at enrollment, 6, and 12 months. Syphilis will be diagnosed using a serum RPR (HUMAN) followed by a treponemal test if positive (Bioline Standard Diagnostics). Chlamydia and gonorrhea will be diagnosed by the urine GeneXpert GT/NG assay.

  6. Acceptability [ Time Frame: 12 months ]
    FANMI Acceptability will be assessed using qualitative interviews conducted at 6 and 12 months after study enrollment with a subset of 30 FANMI participants and clinic providers (nurses and peer educators). A trained qualitative research assistant will interview adolescents to explore attitudes about the FANMI intervention, specifically as it relates to social isolation, stigma, and family rejection, self-esteem and clinic-level factors.

  7. Healthcare utilization [ Time Frame: 12 months ]
    Healthcare utilization will be measured. Healthcare utilization will be measured as a composite of attendance at HIV care visits, laboratory services, and use of other specialist services at study sites and use of health services at non-study sites such as hospitalizations or visits to other medical specialists.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The HIV epidemic in Haiti disproportionally affects adolescent girls age 16-19. Our study involves recruitment and enrollment of adolescent girls to determine if our intervention is effective in retaining HIV-infected adolescent girls in Haiti.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • Age 16-19 years
  • First positive HIV test within 14 days of enrollment
  • Participant knowledge of HIV-infection
  • Lives within 3 miles of clinic
  • Willing to receive care at the clinic or in the community
  • Willing to provide consent (age 18 and 19 years) or assent with parental/guardian consent (16-17 years)

Exclusion Criteria:

  • Prior history of ART use
  • 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

Information from the National Library of Medicine

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): NCT03286504


Contacts
Contact: Margaret McNairy, MD 646-962-8140 mam9365@med.cornell.edu
Contact: Lindsey Reif, MPH 646-962-8140 lir2020@med.cornell.edu

Locations
Haiti
GHESKIO Recruiting
Port-au-Prince, Haiti
Contact: Margaret McNairy, MD, MSc    646-962-8140    mam9365@med.cornell.edu   
Contact: Lindsey Reif, MPH    646-962-8140    lir2020@med.cornell.edu   
Principal Investigator: Daniel Fitzgerald, MD         
Sub-Investigator: Jean Pape, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
Investigators
Principal Investigator: Daniel Fitzgerald, MD Weill Cornell Medicine

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03286504     History of Changes
Other Study ID Numbers: 1504016098
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared once the trial is complete

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No