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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online support group | Behavioral | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Adherence to ART as Measured by the AACTG Adherence Assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa S Dulli, PhD | FHI 360 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SIDHAS-supported facilities | Uyo | Always Ibom | Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30487116 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Online Support Group | Intervention content was delivered online through "secret" Facebook groups that limit membership and access to those invited and added by a group administrator. Intervention components included informational messages and moderated group discussions. Five sessions were included: 1) Understanding HIV; 2) Disclosure and Developing Trust in Relationships; 3) Treatment and Adherence; 4) Nutrition and Health; and 5) Sex and Relationships. Sessions activities included: 1) At-a-glance, introducing the topic of the week; 2) Word of the week, defining one key concept for the topic; 3) Cartoons used to tell a story related to the topic; 4) Key messages to deliver important information; 5) Quizzes to assess participants' knowledge and stimulate discussion; and 6) Group discussions moderated by facilitators. Groups began with an initial, in-person meeting. All participants received a basic cellular phone that could access Facebook, regardless of current phone ownership. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Online Support Group | Intervention content was delivered online through "secret" Facebook groups that limit membership and access to those invited and added by a group administrator. Intervention components included informational messages and moderated group discussions. Five sessions were included: 1) Understanding HIV; 2) Disclosure and Developing Trust in Relationships; 3) Treatment and Adherence; 4) Nutrition and Health; and 5) Sex and Relationships. Sessions activities included: 1) At-a-glance, introducing the topic of the week; 2) Word of the week, defining one key concept for the topic; 3) Cartoons used to tell a story related to the topic; 4) Key messages to deliver important information; 5) Quizzes to assess participants' knowledge and stimulate discussion; and 6) Group discussions moderated by facilitators. Groups began with an initial, in-person meeting. All participants received a basic cellular phone that could access Facebook, regardless of current phone ownership. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who initiated the intervention | Posted | Count of Participants | Participants | 3 months |
|
5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Online Support Group | Intervention content was delivered online through "secret" Facebook groups that limit membership and access to those invited and added by a group administrator. Intervention components included informational messages and moderated group discussions. Five sessions were included: 1) Understanding HIV; 2) Disclosure and Developing Trust in Relationships; 3) Treatment and Adherence; 4) Nutrition and Health; and 5) Sex and Relationships. Sessions activities included: 1) At-a-glance, introducing the topic of the week; 2) Word of the week, defining one key concept for the topic; 3) Cartoons used to tell a story related to the topic; 4) Key messages to deliver important information; 5) Quizzes to assess participants' knowledge and stimulate discussion; and 6) Group discussions moderated by facilitators. Groups began with an initial, in-person meeting. All participants received a basic cellular phone that could access Facebook, regardless of current phone ownership. |
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The non-probability sample precludes generalizing results beyond the study sample.
Social desirability bias may play a role in participants' responses to questions about the intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisa Dulli | FHI 360 | 919-544-7040 | 11396 | ldulli@fhi360.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 2, 2017 | Jun 20, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 29, 2017 | Jun 20, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D000294 | Adolescent Behavior |
| D055118 | Medication Adherence |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Single group pre/post design
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|
Proportion of participants who report not having missed any ART doses in past 3 days. |
| 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. | 3 months |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| religion | Count of Participants | Participants |
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| Time on ART | Mean | Full Range | Years |
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| Education | Count of Participants | Participants |
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| Currently employed | Count of Participants | Participants |
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| Secondary | 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. | Endline participants who participated in the intervention | Posted | Mean | Full Range | Scores on Scale | 3 months |
|
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| Secondary | 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. | Participants who completed end line questionnaire | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | 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. | Participants enrolled in study at baseline | Posted | Count of Participants | Participants | 3 months |
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| 41 |
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| 41 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |