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Acceptability of Depo-subQ in Uniject

This study has been completed.
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
PATH
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01667276
First received: August 2, 2012
Last updated: July 16, 2013
Last verified: July 2013

August 2, 2012
July 16, 2013
July 2012
March 2013   (final data collection date for primary outcome measure)
  • Measure the acceptability of Depo-subQ in Uniject among DMPA IM family planning clients; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Same as current
Complete list of historical versions of study NCT01667276 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    frequencies of reported adverse events by country
Same as current
Not Provided
Not Provided
 
Acceptability of Depo-subQ in Uniject
Acceptability of Depo-subQ in Uniject

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.

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

Observational
Time Perspective: Prospective
Not Provided
Not Provided
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
Contraception
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
476
April 2013
March 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Senegal,   Uganda
 
NCT01667276
10196
No
FHI 360
FHI 360
  • United States Agency for International Development (USAID)
  • PATH
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
FHI 360
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP