Acceptability of Depo-subQ in Uniject
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| ClinicalTrials.gov Identifier: NCT01667276 |
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Recruitment Status
:
Completed
First Posted
: August 17, 2012
Last Update Posted
: July 18, 2013
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| Condition or disease |
|---|
| Contraception |
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 community health workers (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
| Study Type : | Observational |
| Actual Enrollment : | 476 participants |
| Time Perspective: | Prospective |
| Official Title: | Acceptability of Depo-subQ in Uniject |
| Study Start Date : | July 2012 |
| Actual Primary Completion Date : | March 2013 |
| Actual Study Completion Date : | April 2013 |
- Measure the acceptability of Depo-subQ in Uniject among DMPA IM family planning clients; [ Time Frame: 1 year ]percent of participants who declare they would select Depo-subQ in Uniject for their next injection if this drug product was available at three months with a 95% confidence interval per country
- 2) Measure the acceptability of Depo-subQ in Uniject among family planning providers (both clinic-based and CHWs); [ Time Frame: 1 year ]key themes will be identified from interview transcripts to summarize family planning providers' (clinic-based and CHWs) acceptability of Depo-subQ in Uniject and preference for administering Depo-subQ in Uniject relative to the typical DMPA intramuscular injection by county
- Assess family planning providers' (clinic-based and CHWs) training materials. [ Time Frame: 1 year ]descriptive analyses (e.g., frequencies and means) of responses for quantitative questions and summaries providers' qualitative responses to open-ended questions from the post-training evaluation for each country
- 1) To qualitatively compare acceptability of Depo-subQ in Uniject among the two types of family planning providers—clinic-based and CHWs (Senegal only) [ Time Frame: 1 year ]frequencies and summary statistics of acceptability data among family planning clients by asking participants to compare their experiences receiving Depo-subQ in Uniject to their experiences receiving the typical DMPA intramuscular injection by country
- 2) To assess the safety of participants who receive Depo-subQ in Uniject during the study [ Time Frame: 1 year ]frequencies of reported adverse events by country
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| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
Inclusion Criteria:
- Age 18-40
- In general good health (the participant verbally reports she feels well)
- Using DMPA continuously for at least six months prior to enrollment in the study (i.e., had at least two previous injections)
- Received their most recent DMPA injection no more than 13 weeks prior to enrollment in the study at the study clinic or from a family planning provider involved in the study (Senegal only)
- Received their most recent DMPA injection no more than 13 weeks prior to enrollment in the study from a family planning provider involved in the study (Uganda only)
- Desires to be re-injected with DMPA
- Willing to sign an informed consent document
- Willing to provide contact information and be interviewed three months after enrollment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667276
| Senegal | |
| Ministry of Health Clinics | |
| All Cities Where There Is A Clinic, Senegal | |
| Uganda | |
| Ministry of Health Clinics, Uganda | |
| All Cities Where There Is A Clinic, Uganda | |
| Principal Investigator: | Holly Burke, PhD, MPH | FHI 360 | |
| Principal Investigator: | Anthony Mbonye, MD, PhD | Ministry of Health, Uganda | |
| Principal Investigator: | Bpcar M Daff, MD, PhD, MSc | Division de la Sante de la Reproduction |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | FHI 360 |
| ClinicalTrials.gov Identifier: | NCT01667276 History of Changes |
| Other Study ID Numbers: |
10196 |
| First Posted: | August 17, 2012 Key Record Dates |
| Last Update Posted: | July 18, 2013 |
| Last Verified: | July 2013 |
Keywords provided by FHI 360:
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AE adverse event AIDS acquired immunodeficiency syndrome ALT (SGPT) alanine aminotransferase ART antiretroviral therapy AST (SGOT) aspartate aminotransferase DCF data collection forms DMC Data Monitoring Committee FDA (U.S.) Food and Drug Administration GCP Good Clinical Practice guidelines HB sAg Hepatitis B surface antigen ICH International Conference of Harmonisation |
IND Investigational New Drug Application IRB Institutional Review Board IU international units mg milligram(s) mm3 cubic millimeter(s) PCR polymerase chain reaction SAE serious adverse event µg microgram ULN upper limit of the normal range WB Western Blot |