Linkage to Care - Part II
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ClinicalTrials.gov Identifier: NCT00891644 |
Recruitment Status
:
Completed
First Posted
: May 1, 2009
Last Update Posted
: February 28, 2017
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Tracking Information | ||||
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First Submitted Date | April 30, 2009 | |||
First Posted Date | May 1, 2009 | |||
Last Update Posted Date | February 28, 2017 | |||
Study Start Date | June 2009 | |||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Retrospectively recreate the process and timeline of care-seeking among screened HIV positive adolescents. [ Time Frame: 1 year ] | |||
Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT00891644 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
Evaluate technical aspects of identification and recruitment of HIV positive adolescents who have not engaged in care or who have not maintained care. [ Time Frame: 1 year ] | |||
Original Secondary Outcome Measures | Same as current | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Linkage to Care - Part II | |||
Official Title | HIV-Related Care Engagement: Linkage to Care and Care-Seeking for HIV-Infected Adolescents, Phase II | |||
Brief Summary | This is the second phase of a two-phase, cross-sectional study of linkage to medical care of HIV positive youth. Social, psychological and behavioral factors associated with receipt of care will be evaluated. This study will also compare three methods for recruitment of out-of-care youth using a randomized permuted block list of possible sequences. | |||
Detailed Description | ATN 066b consists of a cross-sectional evaluation of three groups of recently diagnosed HIV-infected adolescents including: (1) care non-initiation; (2) care initiation, no maintenance; and (3) care initiation with maintenance. Social, psychological and behavioral factors associated with HIV-related care-seeking will be assessed using an ACASI. Three recruitment strategies using a randomized permuted block list of possible sequences for HIV-infected youth not in care will be also compared. The ACASI instrument will be adapted from previously used instruments intended to retrospectively reconstruct the care-seeking process and to assess quality of life, concerns and expectations for care, satisfaction with care, and social-problem solving. Ideally, the ACASI will be administered during a single session and may take up to 90 minutes to complete. Participants who are unable to complete the ACASI in one session will be allowed up to 7 days after initiation to complete it. Completion of all study data collection, including accrual period, is expected to take approximately 12 months. Outcome measures will be classified as (1) care non-initiation; (2) care initiation, no maintenance; or (3) care initiation and maintenance. The assessment of recruitment strategies most effective for not in care youth will include: use of usual case-management approaches; snowball sampling and venue-based advertisement. |
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Study Type | Observational | |||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population |
Group 1 - HIV positive adolescents who never initiated care within 6 months of receipt of HIV positive results; Group 2 - HIV positive adolescents who initiated care, but did not follow up with care within 12 months of the initial care visit. Also included in this group are those who initiated and followed-up with care, but have dropped out of care for 12 or more months; and Group 3 - HIV positive adolescents who initiated care and maintained care. These youth are currently in care. |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
59 | |||
Original Estimated Enrollment |
150 | |||
Actual Study Completion Date | July 2010 | |||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 14 Years to 24 Years (Child, Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00891644 | |||
Other Study ID Numbers | ATN 066b | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | University of North Carolina, Chapel Hill | |||
Study Sponsor | University of North Carolina, Chapel Hill | |||
Collaborators |
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Investigators |
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PRS Account | University of North Carolina, Chapel Hill | |||
Verification Date | February 2016 |