HIVNCT04442399
Family Connection: Pilot of Family-based Self-management for HIV-infected Adolescents
A study testing Family Connections in people with HIV and Adolescent Behavior, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Zambia.
Trial summary
The study design has two phases. The first phase is the refinement of intervention manual for an adolescent living with HIV (ALHIV)and their caregiver intervention, followed by a second phase feasibility pilot study. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, Adolescent Behavior, Caregivers
- What is being tested?
- Family Connections
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteZambia
- Study dates
- Apr 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adolescents: 15 and 19 years old, aware of their HIV status, and had been on ART for at least six months
- Caregivers:nominated by the adolescents and were at least 20 years old
Who cannot join
- Caregiver: Being a biological parent is not an eligibility criterion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot of Family-based Self-management for HIV-infected Adolescents in Two Clinics in Ndola
The study design has two phases. The first phase is the refinement of intervention manual for an adolescent living with HIV (ALHIV)and their caregiver intervention, followed by a second phase feasibility pilot study. The study goals are to refine and pilot a feasible intervention that fosters resiliency and draws upon the strengths of adolescents and their families. Specific aims include to: (1) Refine activities and an intervention manual for a family-focused group intervention for adolescents and their caregivers to improve HIV self-management among adolescents living with HIV; (2) conduct a pilot study to assess the acceptability and feasibility of the group intervention among 50 adolescent/caregiver pairs that are randomly assigned to the intervention or the comparison arms, and (sub aim 2a) examine preliminary trends in outcome measures, including Anti-Retroviral Therapy (ART) adherence, safer sex behaviors and stigma, comparing the intervention and comparison study arms.
Read the detailed description
The need for effective interventions to support adolescent HIV self-management is particularly pressing in Sub-Saharan Africa (SSA) where the majority of the 2.1 million ALHIV reside. Highlighting the vulnerability of ALHIV is their increasing HIV-related mortality, up 50% in 2012 compared to 2005, while the global number of HIV-related deaths among all ages decreased by 30%. In response to the disparate burden of HIV mortality among ALHIV, combined with the compelling evidence from HIV prevention and chronic illness literature and research on the influential role of families, the study team propose to refine and pilot test an ALHIV/caregiver group intervention. This intervention will draw upon principles of Positive Youth Development (PYD) and Social Cognitive theory (SCT) to emphasize skills building, self-efficacy, youth participation, and strengthening adult relationships. The intervention will build upon an existing ALHIV support group guide and utilize trained facilitators to hold group sessions with ALHIV and their caregivers to: 1) improve understanding of HIV among ALHIV and caregivers; 2) help ALHIV develop strategies for healthy living including adherence to ART; 3) build the capacity of ALHIV to make informed decisions about their sexual and reproductive health; 4) build the capacity of caregivers to support ALHIV; and 5) help ALHIV develop life skills to communicate their HIV diagnosis effectively, and to plan for their future. The study design has two phases. The first phase is the refinement of the ALHIV/caregiver intervention manual followed by a second phase feasibility pilot study. The Study goals are to refine and pilot a feasible intervention that fosters resiliency and draws upon the strengths of adolescents and their families. Specific aims include to: (1) Refine activities and an intervention manual for a family-focused group intervention for adolescents and their caregivers to improve HIV self-management among adolescents living with HIV; (2) conduct a pilot study to assess the acceptability and feasibility of the group intervention among 50 adolescent/caregiver pairs that are randomly assigned to the intervention or the comparison arms, and (sub aim 2a) examine preliminary trends in outcome measures, including ART adherence, safer sex behaviors and stigma, comparing the intervention and comparison study arms.
- Conditions
- HIV, Adolescent Behavior, Caregivers, Africa
- Being tested
- Family Connections
- Keywords
- HIV, Adolescents, Youth, Caregivers, Africa, Intervention
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family ConnectionsBehavioural
Ten intervention sessions were covered, ranging form understanding HIV and to handling stigma and discrimination.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention was based on the WHO-endorsed manual entitled Positive Connections: Leading Information and Support Groups for Adolescents Living with HIV. For Family Connections, a caregiver companion guide was developed. In brief, adolescent/caregiver pairs attended 10 intervention sessions held every other Saturday at their HIV clinic over a six-month period. Receives: Behavioral: Family Connections |
| Comparison | No intervention | The comparison arm consisted of standard of care for adolescents as offered at the HIV clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adolescent/caregiver pairs who attend Family Connections (feasibility)
Feasibility was assessed based on attendance at the intervention sessions.We considered the intervention feasible if at least two-thirds of the pairs attended 80% or more of the intervention sessions.
Measured: Attendance over the course of the 6 month intervention collected using attendance log.
Proportion of participants who would recommend the Family Connections program (acceptability)
The proportion of participants who reported during the endline survey that they would recommend the intervention to others.
Measured: At the six-month endline data collection
Secondary outcomes (3)
Youth Participants' mean ART adherence over six months using daily medication electronic monitoring system (MEMS) caps data
Medication electronic monitoring system (MEMS) caps data recorded the date and time the pill bottle was opened.
Measured: Collected monthly over the course of the six month intervention
Proportion of participants with viral failure (1,000 copies or more per mL)
Defined as having 1,000 or more RNA copies per mL
Measured: ~ 6 months (from baseline to endline)
Youth Participants' adolescent internalized stigma measures (yes/no)
Three agree/disagree statements from the Internalized AIDS Stigma Scale (IA-RSS) as adapted previously in Zambia - low chronbach's alpha resulted in the three measures being analyzed as separate indicators.
Measured: ~ 6 months (from baseline to endline]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study startApr 2016
- Primary completionDec 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- FHI 360
- Responsible party
- Sponsor
- Investigators
- Julie A Denison, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442399
- Sponsor's protocol ID
- IRB00006271
- Status last verified
- Jun 2020
- First submitted
- 18 Jun 2020
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We did not get assent/consent from participants to make their data available to a third party, therefore we are not able to make the data publicly available, rather our consent forms specified the following "the study research team will have access to your data. This team includes the study investigators, research assistants and data analysts".
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of Family-based Self-management for HIV-infected Adolescents in Two Clinics in Ndola
- ClinicalTrials.gov ID
- NCT04442399
- Acronym / sponsor ID
- IRB00006271
- Conditions
- HIV, Adolescent Behavior, Caregivers, Africa
- Keywords
- HIV, Adolescents, Youth, Caregivers, Africa, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- FHI 360
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study design has two phases. The first phase is the refinement of intervention manual for an adolescent living with HIV (ALHIV)and their caregiver intervention, followed by a second phase feasibility pilot study. The study goals are to refine and pilot a feasible intervention that fosters resiliency and draws upon the strengths of adolescents and their families. Specific aims include to: (1) Refine activities and an intervention manual for a family-focused group intervention for adolescents and their caregivers to improve HIV self-management among adolescents living with HIV; (2) conduct a pilot study to assess the acceptability and feasibility of the group intervention among 50 adolescent/caregiver pairs that are randomly assigned to the intervention or the comparison arms, and (sub aim 2a) examine preliminary trends in outcome measures, including Anti-Retroviral Therapy (ART) adherence, safer sex behaviors and stigma, comparing the intervention and comparison study arms.
Detailed description
The need for effective interventions to support adolescent HIV self-management is particularly pressing in Sub-Saharan Africa (SSA) where the majority of the 2.1 million ALHIV reside. Highlighting the vulnerability of ALHIV is their increasing HIV-related mortality, up 50% in 2012 compared to 2005, while the global number of HIV-related deaths among all ages decreased by 30%. In response to the disparate burden of HIV mortality among ALHIV, combined with the compelling evidence from HIV prevention and chronic illness literature and research on the influential role of families, the study team propose to refine and pilot test an ALHIV/caregiver group intervention. This intervention will draw upon principles of Positive Youth Development (PYD) and Social Cognitive theory (SCT) to emphasize skills building, self-efficacy, youth participation, and strengthening adult relationships. The intervention will build upon an existing ALHIV support group guide and utilize trained facilitators to hold group sessions with ALHIV and their caregivers to: 1) improve understanding of HIV among ALHIV and caregivers; 2) help ALHIV develop strategies for healthy living including adherence to ART; 3) build the capacity of ALHIV to make informed decisions about their sexual and reproductive health; 4) build the capacity of caregivers to support ALHIV; and 5) help ALHIV develop life skills to communicate their HIV diagnosis effectively, and to plan for their future. The study design has two phases. The first phase is the refinement of the ALHIV/caregiver intervention manual followed by a second phase feasibility pilot study. The Study goals are to refine and pilot a feasible intervention that fosters resiliency and draws upon the strengths of adolescents and their families. Specific aims include to: (1) Refine activities and an intervention manual for a family-focused group intervention for adolescents and their caregivers to improve HIV self-management among adolescents living with HIV; (2) conduct a pilot study to assess the acceptability and feasibility of the group intervention among 50 adolescent/caregiver pairs that are randomly assigned to the intervention or the comparison arms, and (sub aim 2a) examine preliminary trends in outcome measures, including ART adherence, safer sex behaviors and stigma, comparing the intervention and comparison study arms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Family ConnectionsThe intervention was based on the WHO-endorsed manual entitled Positive Connections: Leading Information and Support Groups for Adolescents Living with HIV. For Family Connections, a caregiver companion guide was developed. In brief, adolescent/caregiver pairs attended 10 intervention sessions held every other Saturday at their HIV clinic over a six-month period. |
| Comparison | No intervention | –The comparison arm consisted of standard of care for adolescents as offered at the HIV clinics. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adolescents: 15 and 19 years old, aware of their HIV status, and had been on ART for at least six months
- Caregivers:nominated by the adolescents and were at least 20 years old
Key exclusion criteria (1 listed)
- Caregiver: Being a biological parent is not an eligibility criterion
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 |
|---|---|---|
| Family ConnectionsTen intervention sessions were covered, ranging form understanding HIV and to handling stigma and discrimination. | Behavioural | Intervention |
Primary outcome
Number of adolescent/caregiver pairs who attend Family Connections (feasibility)
Time frame: Attendance over the course of the 6 month intervention collected using attendance log.
Feasibility was assessed based on attendance at the intervention sessions.We considered the intervention feasible if at least two-thirds of the pairs attended 80% or more of the intervention sessions.
Proportion of participants who would recommend the Family Connections program (acceptability)
Time frame: At the six-month endline data collection
The proportion of participants who reported during the endline survey that they would recommend the intervention to others.
3 secondary outcomes
Youth Participants' mean ART adherence over six months using daily medication electronic monitoring system (MEMS) caps data
Time frame: Collected monthly over the course of the six month intervention
Proportion of participants with viral failure (1,000 copies or more per mL)
Time frame: ~ 6 months (from baseline to endline)
Youth Participants' adolescent internalized stigma measures (yes/no)
Time frame: ~ 6 months (from baseline to endline]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No. We did not get assent/consent from participants to make their data available to a third party, therefore we are not able to make the data publicly available, rather our consent forms specified the following "the study research team will have access to your data. This team includes the study investigators, research assistants and data analysts".
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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.
Julie A Denison, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Connections in people with HIV and Adolescent Behavior, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Zambia.
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 2 inclusion and 1 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 22 Mar 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 Zambia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of adolescent/caregiver pairs who attend Family Connections (feasibility) (time frame: Attendance over the course of the 6 month intervention collected using attendance log.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2023.