FANMI: Community Cohort Care for HIV-Infected Adolescent Girls in Haiti
Phase: NA
Conditions: HIV
Sponsor: Weill Medical College of Cornell University

FANMI: Cohort Care for Adolescents 
Version 1.0 
WCM Protocol: 1504016098 
LOA #1, February 26, 2018 and LOA # 2 October 12, 2018 
 ____________________________________________________________________________________________  
 ____________________________________________________________________________________________  
FANMI: Community Cohort Care for HIV-infected Adolescent Girls in Haiti 
WCM Protocol Number: 
1504016098 
Sponsored by: 
National Institute of Child and Health Development (NICHD), National Institutes of 
Health (NIH) 
Principal Investigator WCM: 
Daniel Fitzgerald, MD 
Principle Investigator GHESKIO: 
Jean William Pape, MD 
Version Number:  
1.0, dated April 11, 2017  
Amendment #1, dated February 26, 2018 
Amendment # 2, dated October 12, 2018 
NCT#03286504

FANMI: Cohort Care for Adolescents  
 
Version 1.0 
WCM Protocol: 1504016098 
LOA #1, February 28, 2018 and LOA # 2, October 12, 2018 
 
 ____________________________________________________________________________________________  
ii 
STATEMENT OF COMPLIANCE 
The study will be carried out in accordance with Good Clinical Practice (GCP) as required by the 
following:  
• 
United States (US) Code of Federal Regulations (CFR) applicable to epidemiological 
studies (45 CFR 46); 
• 
International Conference on Harmonisation (ICH) E6; 62 Federal Register 25691 (1997); 
• 
National Institutes of Health (NIH) Clinical Terms of Award, as applicable; 
• 
Weill Cornell Institutional Review Boards (IRB); 
• 
Groupe Haitien d’Etude du Sarcome et des Infections Opportunties (GHESKIO) IRB; 
• 
International and local requirements. 
Compliance with these standards provides public assurance that the rights, safety and well-
being of study subjects are protected, consistent with the principles that have their origin in the 
Declaration of Helsinki and The Belmont Report: Ethical Principles and Guidelines for the 
Protection of Human Subjects of Research of the US National Commission for the Protection of 
Human Subjects of Biomedical and Behavioral Research (April 18, 1979). 
All key personnel (all individuals responsible for the design and conduct of this study) have 
completed Human Subjects Protection Training. 
The study and consent forms will be approved by an institutional review board at Weill Cornell 
and at GHESKIO. 
 
 

FANMI: Cohort Care for Adolescents  
 
Version 1.0 
WCM Protocol: 1504016098 
LOA #1, February 28, 2018 and LOA # 2, October 12, 2018 
 
 ____________________________________________________________________________________________  
iii 
 
Protocol Summary 
 
Title:   
 
FANMI: Community Cohort Care for HIV-infected Adolescent Girls in Haiti  
 
Study Summary:  
We will conduct a randomized controlled trial titled: FANMI: Community 
Cohort Care for HIV-infected Adolescent Girls in Haiti.  A total of 160 girls 
ages 16-23 will be enrolled and randomized to FANMI (intervention arm) 
or standard individual care (control arm).  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.  The primary outcome is retention 
in HIV care at 12 months after randomization. 
 
Population:  
We will recruit 160 HIV-infected adolescent girls. Inclusion criteria include:  
female; age 16-23 years; ART naïve, initiated ART in the past 3 months, 
or on ART for less than 1 year and defaulted from care for at least 3 
consecutive months; lives in Port au Prince; willing to receive care at 
GHESKIO; willing to provide consent (age 18 – 23 years) or assent with 
parental/guardian consent (16 and 17 years). 
 
Number of Sites:  
Single site: GHESKIO Center Port au Prince, Haiti  
 
Study Duration:  
3 years 
 
 
Subject Duration:  
12 months 
 
Objectives: 
Primary: The primary hypothesis is that FANMI will improve retention at 
12 months compared with standard Individual Care.  The study has > 
80% power to detect a difference in retention from 60% to 85%.   
 
Secondary: A secondary hypothesis is that a greater proportion of the 
FANMI arm will achieve a plasma HIV-1 RNA level < 1000 copies/µl at 12 
months when compared with the Individual Care arm, and this difference 
will be explained by better retention, earlier initiation of ART, and 
improved ART adherence measured by tenofovir diphosphate (TFV-DP) 
levels in dry blood spots. Other study outcomes include sexual behavior 
over the 12-month study, implementation measures including qualitative 
interviews with staff and patients, and a cost-effectiveness analysis of 
FANMI versus Individual Care. 
 
Hypothesis:  
The primary hypothesis is that FANMI will improve retention in HIV care 
at 12 months compared with standard care.  A secondary hypothesis is 

FANMI: Cohort Care for Adolescents  
 
Version 1.0 
WCM Protocol: 1504016098 
LOA #1, February 28, 2018 and LOA # 2, October 12, 2018 
 
 ____________________________________________________________________________________________  
iv 
that a greater proportion of the FANMI arm will achieve a suppressed viral 
load at 12 months when compared with the standard arm. 
 
Primary study endpoint and analysis:  
 
The primary endpoint is alive and in care at 12 months and is a binary 
outcome.  We will compare the proportion of participants who remain alive 
and are retained in HIV care at 12 months between study arms using the 
Fisher exact test.(116-120) This is an individual randomized trial, and we 
anticipate the two arms will have similar baseline characteristics. 
Therefore, the primary analysis will be done without adjusting for baseline 
variables. Since we have one primary outcome, we will test the primary 
hypothesis without multiple testing adjustments. Statistical tests will be 
two-tailed, with a significance level of 0.05.  If some variables at baseline 
are notably imbalanced, we will conduct adjusted analyses as secondary 
or sensitivity analysis using multivariable-adjusted logistic regression and 
Cochran–Mantel–Haenszel statistics. The results will be summarized in 
terms of proportions as well as odds ratio, along with confidence interval 
and statistical significance.  
  
 
Secondary endpoints and analysis:  
 
The secondary endpoint is viral load suppression at 12 months and is a 
binary outcome. We will compare the proportion of participants who have 
viral load suppression at 12 months between study arms using the Fisher 
exact test. Secondary outcomes will be analyzed and reported together 
with clear designation of “secondary” so that readers will be aware of the 
number of pre-specified analyses. Additional secondary end points and 
analyses are discussed in detail in the full protocol below. 
 
    
 

FANMI: Cohort Care for Adolescents  
 
Version 1.0 
WCM Protocol: 1504016098 
LOA #1, February 28, 2018 and LOA # 2, October 12, 2018 
 
 ____________________________________________________________________________________________  
1 
1 
KEY ROLES 
Principle Investigator (WCM): 
Daniel Fitzgerald, MD 
Professor of Medicine 
Center for Global Health 
Weill Cornell Medicine 
402 East 67th Street 
New York, NY 10065 
Work: 646-962-8140 
Email: dwf2001@med.cornell.edu, dfitzgerald@gheskio.org  
Principle Investigator (GHESKIO): 
Jean William Pape, MD 
Professor of Medicine 
Director, GHESKIO Centres 
33 Boulevard Harry Truman 
Port-au-Prince, Haiti  
Work: 509 3702 9366 
Email: jwpape@gheskio.org 
Co-Investigator (WCM): 
Margaret McNairy, MD, MSc 
Assistant Professor of Medicine 
Center for Global Health 
Weill Cornell Medicine 
402 East 67th Street 
New York, NY 10065 
Work: 646-962-8140 
Email: mam9365@med.cornell.edu  
Co-Investigator (WCM): 
Bruce Schackman, PhD 
Professor of Medicine 
Division of Health Services Research 
Weill Cornell Medicine 
402 East 67th Street 
New York, NY 10065 
Work: 646-962-8140 
Email: brs2006@med.cornell.edu 
 
 
Study Coordinator (GHESKIO): 
TBD 
 
GHESKIO Regulatory Coordinator: 

FANMI: Cohort Care for Adolescents  
 
Version 1.0 
WCM Protocol: 1504016098 
LOA #1, February 28, 2018 and LOA # 2, October 12, 2018 
 
 ____________________________________________________________________________________________  
2 
 
 
 
 
Rose Irene Verdier 
Les Centres GHESKIO 
33 Boulevard Harry Truman 
Port-au-Prince, Haiti 
Phone: (305) 720-2530 
Fax: (509) 223-9044 
Email: riv@gheskio.org 
 
 

FANMI: Cohort Care for Adolescents  
 
Version 1.0 
WCM Protocol: 1504016098 
LOA #1, February 28, 2018 and LOA # 2, October 12, 2018 
 
 ____________________________________________________________________________________________  
3 
2 
BACKGROUND INFORMATION AND SCIENTIFIC 
RATIONALE  
2.1 
Background Information  
 
Sexually-active HIV-infected adolescent girls are an extremely vulnerable and underserved 
population, and account for 32% of all new HIV infections in Haiti and a similarly large 
percentage in other resource-poor countries. If treated promptly and retained in care, HIV-
infected adolescents have a near normal life expectancy. Further, ART will decrease sexual and 
vertical HIV transmission in a population who have multiple seronegative sex partners and high 
rates of pregnancy. Long-acting parenteral antiretroviral drugs (e.g. cabotegravir) are currently 
being investigated in clinical trials as a once monthly intramuscular injection. This could be an 
ideal ART regimen for adolescent girls, if they can be retained in care. 
 
However, data from Haiti and other resource-limited settings demonstrate that HIV-infected 
adolescents are not retained in standard clinical care with current procedures. While 
implementation of youth-friendly HIV services has increased HIV testing, linkage to care, and ART 
initiation, retention has not improved. One year after HIV diagnosis, only 54% of adolescents 
remain alive and in care at the GHESKIO Adolescent HIV Clinic. At other HIV clinics in Haiti, less 
than 50% of HIV-infected teens remain in care at 12 months. Reasons for poor retention are 
multifactorial and include adolescent behavior coupled with extreme poverty, social isolation, 
gender inequality, family rejection, and stigma.  
 
This study will validate an integrated, community-based, cohort model of care, FANMI, which 
addresses key environmental, social, and individual factors that influence the retention of HIV-
infected adolescent girls in Haiti.  FANMI addresses social isolation and family rejection by placing 
girls in cohorts of 5-10 peers who meet together each month for HIV care.  The cohorts form 
extremely close peer relationships which are described by teens as surrogate families.  FANMI 
decreases stigma and prioritizes social support by having care visits at a community center, rather 
than in a specialized HIV medical facility.  FANMI integrates peer counseling, social support, and 
medical services into a single session with the same providers, rather than a series of sequential 
encounters with a number of providers as currently happens in the Adolescent HIV Clinic.   
 
Preliminary data from our FANMI pilot study suggest dramatic improvement in outcomes with 91% 
of teens alive and in care at one year. We propose to conduct a randomized controlled trial 
comparing FANMI in the community versus standard of care in the GHESKIO Adolescent Clinic. 
GHESKIO is the premier HIV clinic in Haiti with outcomes superior to other HIV clinics in the 
country.  If community-based FANMI outperforms the GHESKIO clinic, then this will provide gold-
standard evidence for FANMI’s efficacy and for the conduct of large scale implementation studies 
to demonstrate scalability and evaluate cost-effectiveness.  
 

FANMI: Cohort Care for Adolescents  
 
Version 1.0 
WCM Protocol: 1504016098 
LOA #1, February 28, 2018 and LOA # 2, October 12, 2018 
 
 ____________________________________________________________________________________________  
4 
2.2 
Scientific Rationale  
HIV infection rates have declined in all 
segments of the population in Haiti, 
except in adolescents where HIV 
prevalence and mortality rates continue to 
rise. In Haiti, 40% of all new HIV 
infections are in adolescents and 80% of 
these are females. Adolescent girls 
account for 32% of all new HIV infections 
in the country. Sexual intercourse with 
older male partners is the major risk 
factor. The prevalence of HIV is <0.1% in 
13-15 year olds but dramatically increases 
to 2.4% in girls age 19 years (Figure 2). In a 2009 study among adolescents presenting to 
GHESKIO for HIV testing, characteristics and risk factors for HIV infection were different in 
younger (13-15 years) and older (16-19 years) adolescents. Younger teens were 60% male and 
not sexually active.  Risk factors were having a mother with documented HIV infection or being 
an orphan. Older adolescents age 16-19 years were 80% female and 90% were sexually active.  
HIV infection in this older group was associated with not living with parents (O.R 2.0, p <.0001); 
poor relationship with family (OR 1.5, p=.001); never attending school (OR 1.9, p=.003), and 
having a sexually-transmitted infection (STI) (OR 2.3, p < .0001).   
 
Treatment Outcomes in HIV-Infected Adolescents: Studies from multiple resource-poor settings 
demonstrate that adolescents have inferior HIV treatment outcomes compared to adults. Only 
40-60% of HIV-infected adolescents remain alive and in care 12 months after HIV diagnosis 
compared with 65-85% in adults. Viral load suppression is also extremely poor among 
adolescents. These poor outcomes have contributed to a 50% increase in mortality among HIV-
1 infected adolescents over the past decade, as compared to a 30% decrease in mortality in 
HIV-infected adults over the same time period.  The WHO has declared adolescent girls who 
live in settings with a generalized HIV epidemic to be a particularly vulnerable group in need of 
specialized interventions to improve their health outcomes. 
  
GHESKIO Interventions to Improve Adolescent Outcomes:  Since 2003 GHESKIO has 
conducted research and implemented programs to improve HIV services for HIV infected girls 
age 16-23 years. Innovations in community-based testing and implementation of a youth-
friendly Adolescent Clinic improved HIV testing, linkage to care, and rates of ART initiation but 
did not significantly improve long-term retention in care. 
 
 
 
 

FANMI: Cohort Care for Adolescents  
 
Version 1.0 
WCM Protocol: 1504016098 
LOA #1, February 28, 2018 and LOA # 2, October 12, 2018 
 
 ____________________________________________________________________________________________  
5 
2.3 
Potential Risks and Benefits 
Potential Risks 
 
A. Loss of Confidentiality:  All samples and subject data will be coded at the GHESKIO 
Center.  Each subject will be assigned a study identification number consisting of a 
unique code unrelated to any patient identifying information, as per Good Clinical 
Practice guidelines.  Any identifiers linked to the participant will be secured and only 
available to staff at the GHESKIO Center, to ensure subject confidentiality.  All source 
documents will be kept in locked file cabinet. GHESKIO computers and servers are 
protected by firewall protection and are only accessible with a password. 
 
All participants will be counseled on the importance of maintaining confidentiality of the 
HIV status of other patients whom they may see in waiting rooms or during group 
counseling sessions.   
 
B. Social Harms:  Study staff have been working with the Adolescent Community Advisory 
Board (Ado CAB) and are sensitized to the challenges experienced by HIV-infected 
adolescent girls as a vulnerable population.  Additionally, they have been working with 
this population in the Adolescent Clinic for over three years.  As such, they are trained 
on how to respond to any social harm reported by a participant.   
 
C. Discomfort:  As part of the informed consent process, all potential participants will be 
instructed that they do not have to disclose personal information that they are 
uncomfortable sharing and that they can withdraw from the study at any time.  
 
D. Phlebotomy: Participants will be informed of the possible risks of slight bruising or 
tenderness at the site of the blood draw.  They will be encouraged to call or visit the 
study site if symptoms persists or worsen. 
 
Known Potential Benefits 
The results of this study may provide evidence for a new model of HIV care and 
treatment for adolescent HIV-infected girls. Outcomes will be used to better understand 
barriers to retention in HIV care and medication adherence to support future models of 
HIV for adolescent HIV populations.  If clinically and cost-effective, Cohort Care can be 
adapted to similar resource-limited settings.  
If we find that Cohort Care is superior to Standard Care then all participants enrolled in 
this trial will have the option to enroll in Cohort Care. Further, we will transition the 
GHESKIO Adolescent Clinic to a Cohort Care model of care. Finally, Dr. Pape, the Haiti 
Site PI of this proposal, is a senior advisor to the Haitian Ministry of Health, and he will 
work with the Ministry to adopt Cohort Care as a national model of care. Thus we will 
assure that the potential benefits of this study are available to participants and the 
population where the study is conducted. 

FANMI: Cohort Care for Adolescents  
 
Version 1.0 
WCM Protocol: 1504016098 
LOA #1, February 28, 2018 and LOA # 2, October 12, 2018 
 
 ____________________________________________________________________________________________  
6 
3 
STUDY PROTOCOL 
Study Objective 
 
The primary outcome is remaining alive and retained in HIV care at 12 months after 
randomization. The primary hypothesis is that FANMI will increase the proportion alive and in 
care at 12 months compared with standard care.  The study has >80% power to detect a 
difference in the primary study outcome from 60% to 85%. A secondary hypothesis is that a 
greater proportion of the FANMI arm will achieve a suppressed viral load at 12 months when 
compared with the standard arm, and this difference will be explained by better attendance at 
monthly visits and improved ART adherence measured by tenofovir diphosphate (TFV-DP) 
levels in dried blood spots. Other study outcomes include sexual risk behaviors, acceptability of 
FANMI, and health care utilization and costs.  
 
Key Personnel 
 
Daniel Fitzgerald, MD (PI) is a Professor of Medicine, Clinical Epidemiology and Health 
Services Research at Weill Cornell Medical College and will provide overall study leadership. 
Jean Pape, MD is the founding Director of GHESKIO and a pioneer in HIV/AIDS care and 
prevention. Dr. Pape is an adviser to the Haitian Minister of Health and will translate the results 
of the trial into a national adolescent HIV treatment program.  
Margaret McNairy, MD, MSc is an Assistant Professor of Medicine at Cornell and currently 
leads the adolescent community testing and FANMI pilot in Haiti. She will train the study team 
and implement study procedures and data collection.  
Bruce Schackman, PhD is an expert in health economics and has conducted costing analyses 
of PEPFAR and WHO programs in Haiti. He will lead this study’s health care utilization and cost 
analyses. 
 
 
Study Site 
 
The trial will be conducted in Port au Prince Haiti. The standard arm will receive care in the 
GHESKIO Adolescent Clinic located in central Port au Prince.  
 
Study Population  
 
The study population will be 160 HIV-infected adolescent girls. They will be recruited from the 
~370 adolescents who are newly diagnosed with HIV infection at GHESKIO each year.   
 
 
Inclusion and Exclusion Criteria  
 
Inclusion criteria are:  female, age 16-23 years; ART naïve, initiated ART in the past 3 months, or 
on ART for less than 1 year and defaulted from care for at least 3 consecutive months; participant 

FANMI: Cohort Care for Adolescents  
 
Version 1.0 
WCM Protocol: 1504016098 
LOA #1, February 28, 2018 and LOA # 2, October 12, 2018 
 
 ____________________________________________________________________________________________  
7 
knowledge of HIV-infection; lives in Port au Prince; 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 include: pregnancy at the time of enrollment, a severe HIV/AIDS illness requiring 
hospitalization or intensive medical follow-up, or based on the primary clinician’s judgement that 
the adolescent is at a developmental stage not suited for study participation. Based upon our 
experience with the FANMI pilot study, we estimate that 240 (65%) of the newly diagnosed HIV-
infected adolescents each year will satisfy the above entry criteria and be willing to enroll in the 
study. Therefore, over the 18-month enrollment period, we are confident that we can enroll 160 
participants.   
 
Recruitment and Informed Consent 
 
We will recruit HIV-1 infected adolescent girls within 2 weeks of HIV diagnosis while they are 
undergoing initial medical assessment and counseling at the GHESKIO Adolescent Clinic. 
Adolescents who test HIV-positive at GHESKIO are linked to the Adolescent Clinic on the same 
day to initiate medical assessment and counseling by a nurse practitioner. We will also recruit 
HIV-1 infected adolescent girls who were on ART for less than 1 year and defaulted from care for 
at least 3 consecutive months.  At the initial visit, a clinic nurse performs a history, a physical 
exam, orders routine laboratory tests including a CD4 T cell count, and screens for opportunistic 
infections (OIs) including tuberculosis. All patients are eligible for ART per WHO guidelines with 
the goal of initiating ART within 2 weeks of diagnosis.  The first-line ART regimen in Haiti is 
tenofovir (TFV), lamivudine (3TC), and efavirenz (EFV).  Renal dysfunction is rare in 
adolescents in Haiti and > 99% of adolescents start TFV regimens.   
 
At the first clinic visit, the Adolescent Clinic nurse will ask adolescent girls 16-23 years if they are 
interested in participating in the study.  The clinic nurse will accompany interested adolescents to 
the GHESKIO Research Unit to meet a study nurse.  The study nurse is a research staff member 
independent from the clinical team and will not participant in patient care. The research nurse will 
complete a study eligibility checklist and initiate informed consent procedures. The informed 
consent process at GHESKIO consists of two educational sessions and will be completed in the 
first week after HIV diagnosis. Eligible adolescents age >18 years will provide written informed 
consent as an adult participant. Adolescents 16-17 years will be asked to return to the clinic with a 
parent/guardian.  Those who do not provide parental/guardian consent will still be provided with 
free HIV services at GHESKIO.  Adolescents age 16-17 years will provide written informed assent 
and their parent/guardian will provide written informed consent. We will document the number 
screened and reasons for study exclusion. 
 
Study Enrollment and Randomization 
 
Participants who complete the informed consent process will be enrolled in the trial. We will enroll 
consecutively until we reach a sample size of 160 subjects.  The research nurse will assign a 
unique study identification number to each participant, collect demographic and clinical data from 
the EMR, administer a baseline questionnaire, and draw blood and collect urine.  Participants will 
be randomized to either FANMI or Standard Care in a 1:1 ratio using a computer generated 

FANMI: Cohort Care for Adolescents  
 
Version 1.0 
WCM Protocol: 1504016098 
LOA #1, February 28, 2018 and LOA # 2, October 12, 2018 
 
 ____________________________________________________________________________________________  
8 
random assignment.  Subsequent monthly HIV visits for participants randomized to FANMI will be 
in the community center, and participants in the standard arm will be seen in the GHESKIO 
Adolescent Clinic. 
 
 
 
HIV Services and Study Interventions 
 
HIV services provided to all participants in both study arms:  Provision of HIV services including 
ART will adhere to national guidelines in both study arms. Monthly visits will include monitoring for 
new symptoms and assessment for medication toxicity. One month medication refills will be 
provided.  Plasma HIV-1 viral load testing will be performed at enrollment, 6 and 12 months for all 
participants. Patients with a plasma HIV-1 RNA level > 1,000 copies/µl at 6 or 12 months will 
meet with their treatment nurse for an adherence assessment and development of an 
individualized adherence plan per Haitian guidelines. Family planning counseling and 
contraceptive methods will be provided. Girls who become pregnant will continue HIV care at the 
Adolescent Clinic or in FANMI and will also receive three antenatal care visits at the GHESKIO 
obstetric clinic. Prior to transition to adult care, adolescents will receive three counseling sessions 
to facilitate the transition. Participants in the study will benefit from retention support services 
provided to all HIV-infected patients at GHESKIO. All patients are asked to provide a cell phone 
number, another contact phone number, and a nurse routinely calls all patients who miss a visit. 
In addition a home address is recorded and consent is obtained to send a field worker to the 
patient’s home if they miss a visit and cannot be contacted by phone.  
 
All clinical, laboratory and pharmacy information is routinely entered by clinic staff into the 
GHESKIO electronic medical record (EMR).  The GHESKIO Data Management Center operates 
the EMR with data on over 200,000 patients. All clinical data including patient demographics, 
contact information, HIV diagnoses, WHO stage, tuberculosis history, and physical exam findings 
are entered by the nurse in real time at each clinic visit. All laboratory results including HIV-1 viral 
load tests, CD4 T cell counts, and tests for TB and STI are entered directly into the EMR by 
laboratory technicians. Pharmacy records including number and date of all antiretroviral drugs 
dispensed are entered. In the FANMI pilot, clinical data are entered by the nurse onto an 
encryption protected laptop at the community center and then downloaded when the nurse returns 
to GHESKIO. The EMR is programmed in VB.NET, and data are stored in SQL Server with 
multiple backups daily.  
 
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. 
If ART has not been initiated, the nurse will provide individual counseling and ART initiation during 
the monthly visits.  The patient is sequentially referred to the laboratory, social worker, and 
pharmacy for medication refills.  A peer counselor provides counseling on topics chosen by the 
patients and counselor.  A physician is available for consultation. A typical visit, including wait 
time, lasts 3 hours.  
 
FANMI:  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. Cohorts will be formed with at least 2 group members and additional group members 

FANMI: Cohort Care for Adolescents  
 
Version 1.0 
WCM Protocol: 1504016098 
LOA #1, February 28, 2018 and LOA # 2, October 12, 2018 
 
 ____________________________________________________________________________________________  
9 
will be added sequentially. We estimate that it will take 4-8 weeks to constitute a full cohort of 5-
10 teens; monthly meetings will occur while each cohort fills. A visit will start with 30 minutes of 
peer socialization, followed by 45 minutes of group counseling using a structured curriculum. This 
will be followed by a 30 minute social activity. Patients will be seen individually by a nurse for ~10 
minutes during peer socialization or the social activity. CD4 T cell counts will be measured on site 
with the point of care FACSPresto (Becton Dickinson). For HIV viral load and other labs, the nurse 
will collect the samples and transport them to GHESKIO. The nurse will distribute the adolescents’ 
monthly medication refills at the community center. If ART has not been initiated, the nurse will 
provide individual counseling and ART initiation during the monthly visits.  Adolescents with an 
acute illness may be referred to a physician at the GHESKIO HIV clinic.   The nurse will enter 
clinical information into the EMR using a laptop. The entire visit will take ~ 2 hours.  
Cohort members will be encouraged to text or call to remind each other about monthly visits. 
 
Study Measures and Schedule 
 
A questionnaire will be administered at enrollment and months 6 and 12. Data on factors from the 
SAT model will be collected including demographics, HIV knowledge, HIV-related stigma, HIV 
disclosure, social and family support, depression, and alcohol use, problem solving skills, and 
food insecurity. 
 
Clinical characteristics including height, weight, WHO stage, new diagnoses, pregnancies, 
chemistry, hematology tests, and CD4 T cell counts will be extracted from the GHESKIO EMR at 
each study visit. 
 
Alive and in care at 12 months (primary outcome) is defined as being alive at 12 months and 
having a care visit between 11 and 13 months after enrollment. Deaths, cause of deaths, and 
missed care visits are documented in the GHESKIO EMR and will be recorded by the research 
team. 
  
Number of monthly HIV care visits attended is defined as number of monthly care visits 
attended out of 12 possible visits during the study period. We will continue to document the 
number of visits attended after 12 months as a measure of long term retention including visits 
during transitions to adult care.  
 
Plasma HIV-1 RNA levels will be measured in all participants at enrollment and at month 6 and 
12 by the Abbott Real Time PCR Assay with a lower limit of detection of 50 copies/µl. Testing 
will be performed in the GHESKIO Laboratory and results available to clinicians within one 
week. 
 
 
 
 
 
 
 

FANMI: Cohort Care for Adolescents  
 
Version 1.0 
WCM Protocol: 1504016098 
LOA #1, February 28, 2018 and LOA # 2, October 12, 2018 
 
 ____________________________________________________________________________________________  
10 
 
Participants in both study arms will complete three study visits with a research nurse at the 
GHESKIO Research Unit at enrollment, 6, and 12 months. Each study visit will include a 
questionnaire, extraction of clinic attendance and medical information from the GHESKIO EMR, 
and laboratory assessments. An HIV-1 RNA level will be measured at enrollment for research 
purposes and at 6 and 12 months per routine medical care. ART adherence measured by pill 
recalland Tenofovir-DP level in dried blood spots will be measured at  6 and 12 months after ART 
initiation. In addition to the four study visits, a subset of 30 participants in the FANMI arm will be 
recruited for qualitative interviews at 6 months and 12 months with Dr. Jessy Devieux to assess 
acceptability of FANMI. (See section D.2.i for details of these interviews).  This will entail two 
additional study visits for this subset of 30 people. The research team will also contact all 
participants who are not retained in care at 12 months (estimated 12 in FANMI and 32 in the 
standard arm) and invite them to return for a single study visit and qualitative interview to explore 
reasons for non-retention.  
 
 
 
 
 
Study Measures and Schedule 
 
 
Month of Study Visit 
Characteristics 
0 
 
6 
12 
>12 
Demographic information 
X 
 
 
 
 
HIV knowledge and beliefs  
X 
 
X 
X 
 
HIV-related stigma 
X 
 
X 
X 
 
HIV disclosure 
X 
 
X 
X 
 
Social and family support 
X 
 
X 
X 
 
Depression 
X 
 
X 
X 
 
Alcohol and drug use 
X 
 
X 
X 
 
Food insecurity 
X 
 
X 
X 
 
Height, Weight 
X 
 
X 
X 
 
WHO Stage 
X 
 
X 
X 
 
New HIV related diagnoses 
X 
 
X 
X 
 
CD4 T cell count 
X 
 
X 
X 
 
Outcomes 
 
 
 
 
 
Alive and in care at 12 months (primary outcome) 
 
 
 
X 
 
Number of care visits attended 
 
 
X 
X 
X 
Plasma HIV-1 RNA level  
X 
 
X 
X 
 
Time to ART initiation 
 
 
X 
X 
 
ART adherence 
 
 
X 
X 
 
Tenofovir-DP level  
 
 
X 
X 
 
Sexual risk behavior  
X 
 
X 
X 
 
Sexually transmitted infections 
X 
 
X 
X 
 
Pregnancy 
X 
 
X 
X 
 
Health care utilization  
 
 
X 
X 
 

FANMI: Cohort Care for Adolescents  
 
Version 1.0 
WCM Protocol: 1504016098 
LOA #1, February 28, 2018 and LOA # 2, October 12, 2018 
 
 ____________________________________________________________________________________________  
11 
Laboratory 
 
The GHESKIO Clinical Laboratory is the premiere lab in Haiti and is certified by the NIH and CDC 
to perform CD4 T cell counts, HIV-1 viral loads, routine chemistry, hematology, microbiology, and 
assays for the detection of M. tuberculosis and sexually transmitted infections. 
 
Data Collection and Management 
 
Research nurses will abstract clinical and laboratory information from the EMR at each study visit 
and enter the data onto Case Report Forms (CRFs). Research nurses will also administer and 
complete research questionnaires at each visit. GHESKIO laboratory staff will complete a CRF 
with results of plasma HIV-1 RNA levels.  Individuals will be identified by a study ID number and 
no participant identifying information (name, address) will be recorded on questionnaires or 
CRFs. Completed research questionnaires and CRFs will be entered by Adias Marcelin (data 
manager) into the NIH approved REDcap data management system. The REDcap system is 
encrypted and password protected and has been used in prior Cornell-GHESKIO NIH supported 
trials.   Questionnaires and CRFs are entered via an internet interface with data stored at the 
Weill Cornell Clinical and Translational Science Center in New York.  
     
Data Analysis 
  
Aim 1:  Alive and in care at 12 months is a binary outcome.  We will compare the proportion of 
participants who remain alive and are retained in HIV care at 12 months between study arms 
using the Fisher exact test.(116-120) This is an individual randomized trial, and we anticipate the 
two arms will have similar baseline characteristics. Therefore, the primary analysis will be done 
without adjusting for baseline variables. Since we have one primary outcome, we will test the 
primary hypothesis without multiple testing adjustments. Statistical tests will be two-tailed, with a 
significance level of 0.05.  If some variables at baseline are notably imbalanced, we will conduct 
adjusted analyses as secondary or sensitivity analysis using multivariable-adjusted logistic 
regression and Cochran–Mantel–Haenszel statistics. The results will be summarized in terms of 
proportions as well as odds ratio, along with confidence interval and statistical significance. 
Categories of non-retention (i.e., death, lost to follow-up) will be described, and as a secondary 
analysis, we will examine differences between the two arms for these categories.  We will 
analyze cohort effect in the intervention arm in secondary analyses using generalized estimating 
equations. For example, some cohorts of 5-10 girls may perform better than others.  
 
Aim 2a: Viral load suppression at 12 months is a binary outcome. We will compare the proportion 
of participants who have viral load suppression at 12 months between study arms using the Fisher 
exact test. Secondary outcomes will be analyzed and reported together with clear designation of 
“secondary” so that readers will be aware of the number of pre-specified analyses.  
 
Aim 2b: Sexual risk behavior: These include self-reported sexual activity, condom use, incidence 
of sexually-transmitted infections, and pregnancy. For ‘time to event’ outcomes (e.g. time to first 
pregnancy), we will use the Kaplan-Meier estimate and Cox model, along with log-rank test and 

FANMI: Cohort Care for Adolescents  
 
Version 1.0 
WCM Protocol: 1504016098 
LOA #1, February 28, 2018 and LOA # 2, October 12, 2018 
 
 ____________________________________________________________________________________________  
12 
estimation and inference about the hazard ratio. For repeated measures (condom use at each 
visit), we will use statistical methods suited for longitudinal data analysis – (generalized) linear 
mixed effect models that account for correlations within subject. Within these models, intervention, 
time and intervention*time interaction will be included as covariates. For count data aiming at 
estimating rate (number of STIs), we will consider Poisson test and regression. When data are 
severely nonlinear, variable transformation (e.g., log) or nonparametric tests may be adopted, with 
justifications documented.  
 
Aim 2c: Acceptability: All qualitative interviews will be transcribed verbatim, translated in 
English, and then entered into qualitative software (e.g. Atlas-ti) for coding and analysis. A 
thematic coding scheme will be created following the main points of the interview guide.  
 
Aim 2d: Healthcare utilization and costs: Utilization will be summarized for each arm as 
descriptive counts such as number of HIV care visits, laboratory tests, medications, and 
hospitalizations. Unit costs will be determined for each type of healthcare utilization by applying 
labor rates and materials costs available from GHESKIO and other expense costs available 
from previous studies. Differences in costs between arms will be compared using non-
parametric methods if required (e.g. Wilcoxon tests for medians, non-parametric bootstrap for 
means) due to the skewness often found in cost data.  
 
Sample Size and Power 
 
We performed sample size (N)/power calculation using the Fisher exact test for the primary 
outcome in the two independent prospective study arms. With alpha of 5% and with N=80 per 
arm, we will have 93% power to detect a difference between 60% vs. 85% per our primary 
hypothesis. If there is within cohort effect in the FANMI arm, then we will still have 83% power to 
detect a difference in our primary outcome. If we assume potential average within-cohort 
correlation of 5% and cohort sizes of 5-10, the resulting variance inflation factor is 1.3 so that with 
N=80 per arm (or total N of 160), we will have 83% power to detect a difference of 60% vs. 
85%.(126)   Our sample size will also provide reasonable power for important secondary analyses.  
We will have >80% power to detect a difference between 30% and 60% suppressed viral load at 
12 months between the two study arms.  
 
Timeline 
 
In months 1-3, we will finalize study operating procedures, data collection tools, and staff training. 
We will enroll participants in months 4-22 and complete all follow up visits by month 36. In months 
36-42 we will conduct individual interviews, and complete laboratory assays. In months 43-48, we 
will finalize the data set and conduct analysis. Of note, all follow up visits will be completed by 36 
months, and we will be able to report preliminary findings and begin planning for large scale 
implementation studies within three years of initiating this project.