Trial Outcomes & Findings for FANMI: Community Cohort Care for HIV-Infected Adolescent Girls in Haiti (NCT NCT03286504)
NCT ID: 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.
COMPLETED
NA
120 participants
12 months
2023-11-07
Participant Flow
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
| 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
| 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=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
60 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsRetention 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
| 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.
|
|---|---|---|
|
12 Month Retention
|
41 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 12 monthsViral 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
| 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.
|
|---|---|---|
|
12 Month Viral Suppression
|
26 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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
| Measure |
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.
|
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.
|
|---|---|---|
|
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 monthsPopulation: 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
| Measure |
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.
|
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.
|
|---|---|---|
|
Optimal Antiretroviral Therapy (ART) Adherence
|
22 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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
| Measure |
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.
|
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.
|
|---|---|---|
|
Sexual Risk Behavior
|
21 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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
| Measure |
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.
|
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.
|
|---|---|---|
|
Number of Sexually Transmitted Infections
|
10 incident STI diagnoses
|
20 incident STI diagnoses
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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 monthsPopulation: 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
FANMI - Cohort Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place