Acceptability of Depo-subQ in Uniject

Sponsor

FHI 360 (Other)

Overall Status

Completed

CT.gov ID

NCT01667276

Collaborator

United States Agency for International Development (USAID) (U.S. Fed), PATH (Other)

476

Enrollment

Locations

Duration (Months)

238

Patients Per Site

26.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Contraception

Detailed Description

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 Design

Study Type:

Observational

Actual Enrollment :

476 participants

Time Perspective:

Prospective

Official Title:

Acceptability of Depo-subQ in Uniject

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Outcome Measures

Primary Outcome Measures

Measure the acceptability of Depo-subQ in Uniject among DMPA IM family planning clients; [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); [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. [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

Secondary Outcome Measures

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]
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 [1 year]
frequencies of reported adverse events by country

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ministry of Health Clinics	All Cities Where There Is A Clinic		Senegal
2	Ministry of Health Clinics, Uganda	All Cities Where There Is A Clinic		Uganda

Sponsors and Collaborators

FHI 360
United States Agency for International Development (USAID)
PATH

Investigators

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