HIV/AIDSNCT03076996
Youth Power Action Feasibility Study of Online Support Group Intervention Among Adolescents Living With HIV in Nigeria
A study testing Online support group in people with HIV/AIDS and Adolescent Behavior, run by FHI 360 at 1 site in Nigeria.
Trial summary
This study will examine the feasibility and acceptability of an intervention designed to improve retention in HIV care services and improve anti-retroviral therapy (ART) adherence among adolescents ages 15-19 years living with HIV enrolled in ART services. Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Adolescent Behavior, Medication Adherence
- What is being tested?
- Online support group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Jun 2017to 15 Jan 2018
- 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 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- HIV positive and currently on ART for at least 6 months
- Age 15 to 19 years
- Can demonstrate basic literacy necessary to participate in online chats
Who cannot join
- Not planning to remain in the study area (within Akwa Ibom State) for the duration of the study (approximately 6 months)
- Currently enrolled in an in-person support group
- Currently enrolled in another research study related to HIV service retention or ART adherence
- Critically or severely ill requiring hospitalization or such that the individual is unable to provide informed consent at the time of study recruitment
Trial locations and contacts
1 site in 1 country.
About this study
This study will examine the feasibility and acceptability of an intervention designed to improve retention in HIV care services and improve anti-retroviral therapy (ART) adherence among adolescents ages 15-19 years living with HIV enrolled in ART services.
Read the detailed description
Study aim is to examine the feasibility and acceptability of an intervention designed to improve retention in HIV care services and improve anti-retroviral therapy (ART) adherence among adolescents ages 15-19 years living with HIV enrolled in ART services.
A single group, pre/posttest design including structured questionnaires with adolescents living with HIV. Additionally, we will abstract clinical data from the medical record system. We will also conduct in-depth interviews with a subset of participants, as well as health care staff who are engaged in the intervention, at endline.
The objectives of this study are:
- To examine the feasibility of implementing a mobile/electronic health (m/eHealth) intervention designed to improve retention in HIV care services and ART adherence among ALHIV ages 15-19 years through an online support group (using Facebook).
- To assess acceptability of and engagement in the intervention by the target audience to inform improvements to the intervention.
- To gather preliminary data on the psycho-social and health-related outcomes that the intervention is designed to affect to inform an outcome evaluation study that will be conducted following the conclusion of the feasibility study.
- To collect information on recruitment, informed consent and data collection processes to inform the outcome evaluation study of the current intervention that will be conducted once findings from this feasibility study are incorporated into the intervention design.
- Conditions
- HIV/AIDS, Adolescent Behavior, Medication Adherence, Health Behavior
- Being tested
- Online support group
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Adolescent Behavior, Medication Adherence, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online support groupBehavioural
Participants will be enrolled to form five groups of 8 to 10 participants, and then participants will participate in the 6 sessions of the structured educational and group counseling curriculum through the online platform.
The m/eHealth intervention components include:
- Informational messages that reflect the content of the structured group counseling curriculum, Positive Connections, and are posted to the group wall on a regular basis
- Moderated, closed group chats where ALHIV can interact with their peers and with a trained health counselor on a biweekly basis
- Access to a trained counselor via Facebook Messenger (during normal business hours) for the duration of the intervention who will be able to provide information or basic counseling on ART/HIV care related issues, with referral to health care services as needed
| Study group | Role | What they receive |
|---|---|---|
| Online support group | Experimental | Participants will be enrolled to receive six sessions from the Positive Connections curriculum through the m/eHealth intervention that will use Facebook to conduct online structured support groups. Receives: Behavioral: Online support group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Active Members Who Have at Least One Post in Group Chat Session.
Participants level of engagement in support group activities informs on the feasibility of intervention, measured by percentage of active members who have at least one post in group chat session.
Measured: 3 months
Secondary outcomes (3)
Acceptability Score
Acceptability score: A set of ten items asking if participants agreed=1 or disagreed=0 with statements on acceptability. Score represents a sum of the 10 items with a range of 0 to 10, and a greater number indicating agreement with more acceptability items.
Measured: 3 months
Adherence to ART as Measured by the AACTG Adherence Assessment
Proportion of participants who report not having missed any ART doses in past 3 days.
Measured: 3 months
Adherence to Follow-up Visit Within 1 Month of Scheduled Date
Retention in HIV services will be measured using data abstracted from the medical record system on date of visits between enrollment and the endline of this study. To be considered retained in HIV services, an individual must, at 3 months after enrollment, have attended his/her most recently scheduled clinical follow-up visit within 1 month of the date when it was scheduled to take place.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start1 Jun 2017
- Primary completion15 Jan 2018
- Study completion15 Jan 2018
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 HIV/AIDSStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single group pre/post design
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa S Dulli, PhD, Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076996
- Sponsor's protocol ID
- 930307
- Status last verified
- Feb 2019
- First submitted
- 8 Feb 2017
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dulli L, Ridgeway K, Packer C, Plourde KF, Mumuni T, Idaboh T, Olumide A, Ojengbede O, McCarraher DR. An Online Support Group Intervention for Adolescents Living with HIV in Nigeria: A Pre-Post Test Study. JMIR Public Health Surveill. 2018 Nov 28;4(4):e12397. doi: 10.2196/12397.
PubMed 30487116
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Youth Power Action Feasibility Study of Online Support Group Intervention Among Adolescents Living With HIV in Nigeria
- ClinicalTrials.gov ID
- NCT03076996
- Acronym / sponsor ID
- 930307
- Conditions
- HIV/AIDS, Adolescent Behavior, Medication Adherence, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Posted 18 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the feasibility and acceptability of an intervention designed to improve retention in HIV care services and improve anti-retroviral therapy (ART) adherence among adolescents ages 15-19 years living with HIV enrolled in ART services.
Detailed description
Study aim is to examine the feasibility and acceptability of an intervention designed to improve retention in HIV care services and improve anti-retroviral therapy (ART) adherence among adolescents ages 15-19 years living with HIV enrolled in ART services.
A single group, pre/posttest design including structured questionnaires with adolescents living with HIV. Additionally, we will abstract clinical data from the medical record system. We will also conduct in-depth interviews with a subset of participants, as well as health care staff who are engaged in the intervention, at endline.
The objectives of this study are:
- To examine the feasibility of implementing a mobile/electronic health (m/eHealth) intervention designed to improve retention in HIV care services and ART adherence among ALHIV ages 15-19 years through an online support group (using Facebook).
- To assess acceptability of and engagement in the intervention by the target audience to inform improvements to the intervention.
- To gather preliminary data on the psycho-social and health-related outcomes that the intervention is designed to affect to inform an outcome evaluation study that will be conducted following the conclusion of the feasibility study.
- To collect information on recruitment, informed consent and data collection processes to inform the outcome evaluation study of the current intervention that will be conducted once findings from this feasibility study are incorporated into the intervention design.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group pre/post design
| Arm | Type | Receives |
|---|---|---|
| Online support group | Experimental | Behavioral: Online support groupParticipants will be enrolled to receive six sessions from the Positive Connections curriculum through the m/eHealth intervention that will use Facebook to conduct online structured support groups. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- HIV positive and currently on ART for at least 6 months
- Age 15 to 19 years
- Can demonstrate basic literacy necessary to participate in online chats
Key exclusion criteria (4 listed)
- Not planning to remain in the study area (within Akwa Ibom State) for the duration of the study (approximately 6 months)
- Currently enrolled in an in-person support group
- Currently enrolled in another research study related to HIV service retention or ART adherence
- Critically or severely ill requiring hospitalization or such that the individual is unable to provide informed consent at the time of study recruitment
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 |
|---|---|---|
| Online support groupParticipants will be enrolled to form five groups of 8 to 10 participants, and then participants will participate in the 6 sessions of the structured educational and group counseling curriculum through the online platform. The m/eHealth intervention components include: * Informational messages that reflect the content of the structured group counseling curriculum, Positive Connections, and are posted to the group wall on a regular basis * Moderated, closed group chats where ALHIV can interact with their peers and with a trained health counselor on a biweekly basis * Access to a trained counselor via Facebook Messenger (during normal business hours) for the duration of the intervention who will be able to provide information or basic counseling on ART/HIV care related issues, with referral to health care services as needed | Behavioural | Online support group |
Primary outcome
Percentage of Active Members Who Have at Least One Post in Group Chat Session.
Time frame: 3 months
Participants level of engagement in support group activities informs on the feasibility of intervention, measured by percentage of active members who have at least one post in group chat session.
3 secondary outcomes
Acceptability Score
Time frame: 3 months
Adherence to ART as Measured by the AACTG Adherence Assessment
Time frame: 3 months
Adherence to Follow-up Visit Within 1 Month of Scheduled Date
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30487116Dulli L, Ridgeway K, Packer C, Plourde KF, Mumuni T, Idaboh T, Olumide A, Ojengbede O, McCarraher DR. An Online Support Group Intervention for Adolescents Living with HIV in Nigeria: A Pre-Post Test Study. JMIR Public Health Surveill. 2018 Nov 28;4(4):e12397. doi: 10.2196/12397.
- Individual participant dataSharing planned: No
Related trials for HIV/AIDS
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Lisa S Dulli, PhD principal investigator
FHI 360
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online support group in people with HIV/AIDS and Adolescent Behavior, run by FHI 360 at 1 site in Nigeria.
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 3 inclusion and 4 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 5 Mar 2019. 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 Nigeria. 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 18 Feb 2019). 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?
Percentage of Active Members Who Have at Least One Post in Group Chat Session. (time frame: 3 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 NCT03076996, 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 5 Mar 2019.