HIV/AIDS Clinical Trial
— ACTOfficial title:
Adolescent Coordinated Transition (ACT) to Improve Health Outcomes Among Nigerian HIV+ Youth
The purpose of this study is to evaluate the comparative effectiveness of a comprehensive, coordinated transition protocol which includes an early introduction to the adult provider, an integrated case management team and a peer-facilitated organized support group on retention in care, viral suppression and psychosocial wellbeing among adolescents living with HIV.
Status | Recruiting |
Enrollment | 216 |
Est. completion date | June 30, 2021 |
Est. primary completion date | May 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 17 Years |
Eligibility |
Inclusion Criteria: - Documented HIV infection - Aware of HIV diagnosis - Currently on ART Exclusion Criteria: - Medically unstable |
Country | Name | City | State |
---|---|---|---|
Nigeria | Center for Integrated Health Program | Abuja | |
Nigeria | Centre for Clinical Care and Research | Abuja | |
Nigeria | Family Health International | Abuja | |
Nigeria | Institute of Human Virology | Abuja | FCT |
Nigeria | AIDS Prevention Initiative Nigeria | Lagos |
Lead Sponsor | Collaborator |
---|---|
University of Nevada, Las Vegas | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Nigeria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Retention in care in care 6 months post-transfer | Proportion of participants who had at least 1 clinical visit to an HIV provider within the 6 months post-transfer | 6 months | |
Primary | Retention in care 12 months post-transfer | Proportion of participants who had at least 2 clinical visits to an HIV provider separated by 6 months within the 1 year period post-transfer | 12 months | |
Primary | Retention in care 24 months post-transfer | Proportion of participants who had at least 2 clinical visits to an HIV provider separated by 6 months within a 1 year period during the second year post-transfer | 24 months | |
Secondary | Viral Suppression | Proportion of participants with undetectable viral load | Enrollment, baseline (12 months), 24 and 36 months | |
Secondary | Mental Health and Wellbeing | Mental health continuum-short form Questionnaire | Enrollment, baseline (12 months), 24 and 36 months | |
Secondary | Health Locus of Control | Health Locus of control / Self-esteem Questionnaire | Enrollment, baseline (12 months), 24 and 36 months | |
Secondary | Social Support | Functional Social Support Questionnaire | Enrollment, baseline (12 months), 24 and 36 months | |
Secondary | Sexual Risk Behavior | Sexual Risk Beliefs and Behavior Self Efficacy Questionnaire | Enrollment, baseline (12 months), 24 and 36 months | |
Secondary | Transition Readiness | Transition Readiness Assessment Questionnaire | Enrollment, baseline (12 months), 24 and 36 months |
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