Youth Power Action Feasibility Study of Online Support Group Intervention Among Adolescents Living With HIV in Nigeria
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ClinicalTrials.gov Identifier: NCT03076996 |
Recruitment Status :
Completed
First Posted : March 10, 2017
Results First Posted : February 18, 2019
Last Update Posted : March 5, 2019
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Condition or disease | Intervention/treatment | Phase |
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HIV/AIDS Adolescent Behavior Medication Adherence Health Behavior | Behavioral: Online support group | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 41 participants |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Single group pre/post design |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Youth Power Action Feasibility Study of Online Support Group Intervention Among Adolescents Living With HIV in Nigeria |
Actual Study Start Date : | June 1, 2017 |
Actual Primary Completion Date : | January 15, 2018 |
Actual Study Completion Date : | January 15, 2018 |
Arm | Intervention/treatment |
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Experimental: Online support group
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.
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Behavioral: Online support group
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:
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- 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.
- Acceptability Score [ Time Frame: 3 months ]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.
- Adherence to ART as Measured by the AACTG Adherence Assessment [ Time Frame: 3 months ]Proportion of participants who report not having missed any ART doses in past 3 days.
- Adherence to Follow-up Visit Within 1 Month of Scheduled Date [ Time Frame: 3 months ]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.

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Ages Eligible for Study: | 15 Years to 19 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076996
Nigeria | |
SIDHAS-supported facilities | |
Uyo, Always Ibom, Nigeria |
Principal Investigator: | Lisa S Dulli, PhD | FHI 360 |
Documents provided by FHI 360:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | FHI 360 |
ClinicalTrials.gov Identifier: | NCT03076996 History of Changes |
Other Study ID Numbers: |
930307 |
First Posted: | March 10, 2017 Key Record Dates |
Results First Posted: | February 18, 2019 |
Last Update Posted: | March 5, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |