Acceptability of Depo-subQ in Uniject
Information source: FHI 360
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Phase: N/A
Status: Completed
Sponsored by: FHI 360 Official(s) and/or principal investigator(s): Holly Burke, PhD, MPH, Principal Investigator, Affiliation: FHI 360 Anthony Mbonye, MD, PhD, Principal Investigator, Affiliation: Ministry of Health, Uganda Bpcar M Daff, MD, PhD, MSc, Principal Investigator, Affiliation: Division de la Sante de la Reproduction
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.
Clinical Details
Official title: Acceptability of Depo-subQ in Uniject
Study design: Time Perspective: Prospective
Primary outcome: Measure the acceptability of Depo-subQ in Uniject among DMPA IM family planning clients;2) Measure the acceptability of Depo-subQ in Uniject among family planning providers (both clinic-based and CHWs); Assess family planning providers' (clinic-based and CHWs) training materials.
Secondary outcome: 1) To qualitatively compare acceptability of Depo-subQ in Uniject among the two types of family planning providers—clinic-based and CHWs (Senegal only)2) To assess the safety of participants who receive Depo-subQ in Uniject during the study
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 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
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
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
Additional Information
Starting date: July 2012
Last updated: July 16, 2013
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