Acceptability of Depo-subQ in Uniject
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| First Received Date ICMJE | August 2, 2012 | ||||||||||||
| Last Updated Date | March 5, 2013 | ||||||||||||
| Start Date ICMJE | July 2012 | ||||||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT01667276 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Acceptability of Depo-subQ in Uniject | ||||||||||||
| Official Title ICMJE | Acceptability of Depo-subQ in Uniject | ||||||||||||
| Brief Summary | This is an observational study to assess the experience of current depot medroxyprogesterone acetate (DMPA) intramuscular (IM) clients and providers when they try Depo-subQ in Uniject and offer recommendations for the introduction of this method. |
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| Detailed Description | This is an observational study to assess the experience of current depot medroxyprogesterone acetate (DMPA) intramuscular (IM) clients and providers when they try Depo-subQ in Uniject and offer recommendations for the introduction of this method. A total of 560 participants will be enrolled in the study in the following groups: 360 participants (120 in Uganda and 240 in Senegal) who are current DMPA IM clients who seek re-injection of DMPA from either CHWs or clinic-based providers; and are 18-40 years of age; received their most recent DMPA injection no more than 13 weeks prior to enrollment in the study [16]. Up to 100 participants (50 in Uganda and 50 in Senegal) current DMPA IM clients who meet the inclusion/exclusion criteria but do not want to receive the injection with Depo-subQ in Uniject and are willing to complete a short questionnaire 80 CHWs (40 in Uganda and 40 in Senegal) and 20 clinic-based providers (from Senegal only) who are trained to give Depo-subQ in Uniject as part of this study |
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| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||||||
| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Not Provided | ||||||||||||
| Sampling Method | Non-Probability Sample | ||||||||||||
| Study Population | A total of 560 participants will be enrolled in the study in the following groups:
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| Condition ICMJE | Contraceptive Acceptability | ||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||||||
| Publications * | Not Provided | ||||||||||||
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* 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 ICMJE | Active, not recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 560 | ||||||||||||
| Estimated Completion Date | May 2013 | ||||||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Female | ||||||||||||
| Ages | 18 Years to 40 Years | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Senegal, Uganda | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01667276 | ||||||||||||
| Other Study ID Numbers ICMJE | 10196 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | FHI 360 | ||||||||||||
| Study Sponsor ICMJE | FHI 360 | ||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | FHI 360 | ||||||||||||
| Verification Date | August 2012 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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