Trial Outcomes & Findings for FANMI: Community Cohort Care for HIV-Infected Adolescent Girls in Haiti (NCT NCT03286504)

Last Updated: 2023-11-07

Results Overview

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 9 and 15 months after enrollment.

Recruitment status

COMPLETED

Study phase

Target enrollment

120 participants

Primary outcome timeframe

12 months

Results posted on

2023-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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. 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.
Overall Study STARTED	60	60
Overall Study COMPLETED	41	44
Overall Study NOT COMPLETED	19	16

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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. 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.
Overall Study Lost to Follow-up	19	16

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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 9 and 15 months after enrollment.

Outcome measures

Outcome measures
Measure	FANMI - Cohort Care n=60 Participants 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. 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.	Standard-of-care n=60 Participants 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.
12 Month Retention	44 Participants	41 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	FANMI - Cohort Care n=60 Participants 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. 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.	Standard-of-care n=60 Participants 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.
12 Month Viral Suppression	28 Participants	26 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Participants analyzed were only those who were ART-naïve at study enrollment.

Time to ART initiation is the number of calendar days from date of HIV diagnosis to date of ART initiation.

Outcome measures

Outcome measures
Measure	FANMI - Cohort Care n=33 Participants 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. 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.	Standard-of-care n=34 Participants 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.
Time to Antiretroviral Therapy (ART) Initiation	0 days Interval 0.0 to 0.0	0 days Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 12 months

Population: There were 18 participants in the SOC arm and 22 participants in the FANMI arm who chose not to respond to the ART adherence assessment and were not included in this analysis.

ART adherence will be measured by self-report using two questions: 1) number of pills missed in the past 4 days and 2) forgot to take pills last weekend. A response of no missed pills in the past 4 days and did not forget to take pills last weekend is defined as 'optimal' adherence. All other responses are defined as 'sub-optimal' adherence.

Outcome measures

Outcome measures
Measure	FANMI - Cohort Care n=38 Participants 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. 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.	Standard-of-care n=42 Participants 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.
Optimal Antiretroviral Therapy (ART) Adherence	18 Participants	22 Participants

SECONDARY outcome

Timeframe: 12 months

Population: There were 21 participants in the SOC arm and 26 subjects in the FANMI arm that did not receive STI testing and were excluded from this analysis.

Sexual risk behavior will be measured by regular condom use among those who are sexually active. Regular condom use is defined as a response of 'often' or 'always' when asked about condom use during sexual intercourse.

Outcome measures

Outcome measures
Measure	FANMI - Cohort Care n=34 Participants 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. 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.	Standard-of-care n=39 Participants 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.
Sexual Risk Behavior	26 Participants	21 Participants

SECONDARY outcome

Timeframe: 12 months

Population: There were 14 participants in the SOC arm and 13 subjects in the FANMI arm that did not receive STI testing and were excluded from this analysis.

Sexually Transmitted Infections will include syphilis, diagnosed using a serum RPR (HUMAN) followed by a treponemal test if positive (Bioline Standard Diagnostics), chlamydia and gonorrhea, diagnosed by the urine GeneXpert GT/NG assay.

Outcome measures

Outcome measures
Measure	FANMI - Cohort Care n=47 Participants 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. 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.	Standard-of-care n=46 Participants 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.
Number of Sexually Transmitted Infections	20 incident STI diagnoses	10 incident STI diagnoses

SECONDARY outcome

Timeframe: 12 months

Population: Data for this outcome was not collected.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Data not collected.

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.

Outcome measures

Outcome data not reported

Adverse Events

Standard-of-care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

FANMI - Cohort Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Fitzgerald

Weill Cornell Medicine

Phone: 646-962-8140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Standard-of-care n=60 Participants 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.	FANMI - Cohort Care n=60 Participants 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. 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.	Total n=120 Participants Total of all reporting groups
Age, Categorical <=18 years	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=5 Participants	50 Participants n=7 Participants	104 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	60 Participants n=7 Participants	120 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=5 Participants	60 Participants n=7 Participants	120 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	60 Participants n=5 Participants	60 Participants n=7 Participants	120 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants