NCT01667276|Completed
Loading search results
Sponsor study identifier
observational
476
2 countries
2
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2013
Actual (reported)Study Completion
April 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
August 2, 2012
Actual (reported)August 17, 2012
Actual (reported)March 2013
Actual (reported)April 2013
Actual (reported)Measure the acceptability of Depo-subQ in Uniject among DMPA IM family planning clients;
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
1 year
2) Measure the acceptability of Depo-subQ in Uniject among family planning providers (both clinic-based and CHWs);
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
1 year
Assess family planning providers' (clinic-based and CHWs) training materials.
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
Ministry of Health Clinics
All Cities Where There Is A Clinic, Senegal
Ministry of Health Clinics, Uganda
All Cities Where There Is A Clinic, Uganda
Burke HM, Mueller MP, Perry B, Packer C, Bufumbo L, Mbengue D, Mall I, Daff BM, Mbonye AK. Observational study of the acceptability of Sayana(R) Press among intramuscular DMPA users in Uganda and Senegal. Contraception. 2014 May;89(5):361-7. doi: 10.1016/j.contraception.2014.01.022. Epub 2014 Feb 6.
Burke HM, Mueller MP, Packer C, Perry B, Bufumbo L, Mbengue D, Daff BM, Mbonye A. Provider acceptability of Sayana(R) Press: results from community health workers and clinic-based providers in Uganda and Senegal. Contraception. 2014 May;89(5):368-73. doi: 10.1016/j.contraception.2014.01.009. Epub 2014 Jan 21.
Holly Burke, PhD, MPH
FHI 360
Anthony Mbonye, MD, PhD
Ministry of Health, Uganda
Bpcar M Daff, MD, PhD, MSc
Division de la Sante de la Reproduction
476 participants (actual enrollment reported by the registry).
First Submitted
August 2, 2012
First Posted
August 17, 2012
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Long-Acting Reversible Contraception
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 year
1) To qualitatively compare acceptability of Depo-subQ in Uniject among the two types of family planning providers-clinic-based and CHWs (Senegal only)
1 year
2) To assess the safety of participants who receive Depo-subQ in Uniject during the study
1 year
Contact the study team to confirm eligibility.
Primary Completion
March 2013
Actual (reported)Study Completion
April 2013
Actual (reported)Last Updated
July 18, 2013
Record last verified: 2013-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: