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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 October 2022 |
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Main ID: |
NCT02702895 |
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Date of registration:
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31/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Assessment of ASPIRE and HOPE Adherence
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Scientific title:
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Assessment of ASPIRE and HOPE Adherence |
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Date of first enrolment:
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June 13, 2016 |
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Target sample size:
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302 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02702895 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Malawi
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South Africa
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Uganda
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Zimbabwe
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Contacts
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Name:
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Elizabeth Montgomery, PhD, MHS |
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Address:
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Telephone:
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Email:
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Affiliation:
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RTI International |
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Key inclusion & exclusion criteria
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Inclusion Criteria (Phase 1 - Former ASPIRE participants):
1. Participated in the ASPIRE protocol, randomized to active product and informed of
their randomization assignment.
2. Able and willing to provide written informed consent in one of the study languages.
3. Able and willing to complete the required study procedures.
4. For participants who did not acquire an HIV infection while taking part in ASPIRE,
evidence of study product dispensation at a minimum of three consecutive ASPIRE
scheduled clinic visits. For participants who acquired an HIV infection while taking
part in ASPIRE, evidence of study product dispensation in the month prior to the
participant's acquisition of HIV infection.
5. For participants who did not acquire an HIV infection while taking part in ASPIRE,
have a minimum of three ASPIRE PK data measurement points available. For participants
who acquired HIV infection while taking part in ASPIRE, have a minimum of one ASPIRE
PK data measurement available.
Inclusion Criteria (Phase 2 - HOPE participants):
1. Participated in the HOPE protocol.
2. Able and willing to provide written informed consent in one of the study languages.
3. Able and willing to complete the required study procedures.
4. For participants who did not acquire an HIV infection while taking part in HOPE,
evidence of study product dispensation for a minimum of three consecutive months.
5. For participants who acquired an HIV infection while taking part in HOPE, evidence of
study product dispensation in the month prior to the participant's acquisition of an
HIV infection.
Inclusion Criteria (Phase 2 - Male partners of HOPE participants):
1. Identifies as a male sexual partner of a HOPE participant for whom the HOPE
participant has given permission to contact.
2. Was a male sexual partner of a HOPE participant during her participation in HOPE
(regardless of whether she used the ring or not).
3. Able and willing to provide written informed consent in one of the study languages.
4. Able and willing to complete the required study procedures.
5. Is above the age of 18 at the time of study participation.
Exclusion Criteria (Phase 1 and Phase 2):
1. Has any significant medical condition or other condition that, in the opinion of the
Investigator of Record (IoR)/designee, would preclude informed consent, make study
participation unsafe, complicate interpretation of study outcome data, or otherwise
interfere with achieving the study objectives.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV Prevention
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Intervention(s)
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Behavioral: In-depth Interview (IDIs) or Focus Group Discussion (FGD)
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Primary Outcome(s)
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Male partner attitudes affecting product use adherence
[Time Frame: Phase 2: Nine to twelve months during Q2 2018/Q2 2019.]
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Factors affecting product use adherence
[Time Frame: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.]
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Secondary Outcome(s)
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Product use patterns
[Time Frame: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.]
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Perceptions of various adherence support interventions
[Time Frame: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.]
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Perceptions of HIV risk
[Time Frame: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.]
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Understanding of ASPIRE results and ring efficacy
[Time Frame: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.]
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Secondary ID(s)
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UM1AI106707
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UM1AI068633
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MTN-032
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Protocol ID#12058
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UM1AI068615
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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