HIVNCT03286504
FANMI: Community Cohort Care for HIV-Infected Adolescent Girls in Haiti
A study testing FANMI - Cohort Care in people with HIV, run by Weill Medical College of Cornell University at 1 site in Haiti.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 23 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- FANMI - Cohort Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteHaiti
- Study dates
- 25 May 2018to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 23 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HIV
- Being tested
- FANMI - Cohort Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FANMI - Cohort CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-care | No intervention | 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 | Experimental | 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. Receives: Behavioral: FANMI - Cohort Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 Month Retention
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.
Measured: 12 months
Secondary outcomes (7)
12 Month Viral Suppression
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.
Measured: 12 months
Time to Antiretroviral Therapy (ART) Initiation
Time to ART initiation is the number of calendar days from date of HIV diagnosis to date of ART initiation.
Measured: 12 months
Optimal Antiretroviral Therapy (ART) Adherence
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.
Measured: 12 months
Sexual Risk Behavior
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.
Measured: 12 months
Number of Sexually Transmitted Infections
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.
Measured: 12 months
Acceptability
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.
Measured: 12 months
Healthcare Utilization
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start25 May 2018
- Primary completion1 Jun 2022
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Daniel Fitzgerald, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286504
- Sponsor's protocol ID
- 1504016098
- Other IDs
- R01HD091935
- Status last verified
- Oct 2023
- First submitted
- 13 Sep 2017
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared once the trial is complete
Publications
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.
PubMed 31888569
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FANMI: Community Cohort Care for HIV-Infected Adolescent Girls in Haiti
- ClinicalTrials.gov ID
- NCT03286504
- Acronym / sponsor ID
- 1504016098
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 25 May 2018 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Posted 2 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care | No intervention | –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 | Experimental | Behavioral: FANMI - Cohort CareAdolescents 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. |
Who may qualify
- Ages
- 16 to 23 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FANMI - Cohort CareFANMI 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. | Behavioural | FANMI - Cohort Care |
Primary outcome
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 9 and 15 months after enrollment.
7 secondary outcomes
12 Month Viral Suppression
Time frame: 12 months
Time to Antiretroviral Therapy (ART) Initiation
Time frame: 12 months
Optimal Antiretroviral Therapy (ART) Adherence
Time frame: 12 months
Sexual Risk Behavior
Time frame: 12 months
Number of Sexually Transmitted Infections
Time frame: 12 months
Acceptability
Time frame: 12 months
Healthcare Utilization
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31888569Seo 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.
- Individual participant dataSharing planned: Yes. Data will be shared once the trial is complete
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Fitzgerald, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FANMI - Cohort Care in people with HIV, run by Weill Medical College of Cornell University at 1 site in Haiti.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Haiti. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12 Month Retention (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03286504, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.