Acceptability of Depo-subQ in Uniject

Contraception Clinical Trial

Official title:

Acceptability of Depo-subQ in Uniject

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667276
• Other study ID #: 10196
• Status: Completed
• Phase: N/A
• First received: August 2, 2012
• Last updated: July 16, 2013
• Start date: July 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2013
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 476
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraception

Locations

Country	Name	City	State
Senegal	Ministry of Health Clinics	All Cities Where There Is A Clinic
Uganda	Ministry of Health Clinics, Uganda	All Cities Where There Is A Clinic

Sponsors (3)

Lead Sponsor	Collaborator
FHI 360	PATH, United States Agency for International Development (USAID)

Countries where clinical trial is conducted

Senegal,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Assess family planning providers' (clinic-based and CHWs) training materials.	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	No
Secondary	1) To qualitatively compare acceptability of Depo-subQ in Uniject among the two types of family planning providers—clinic-based and CHWs (Senegal only)	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	1 year	No
Secondary	2) To assess the safety of participants who receive Depo-subQ in Uniject during the study	frequencies of reported adverse events by country	1 year	No