Acceptability of Depo-subQ in Uniject - Full Text View

Purpose

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
Contraception


Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Acceptability of Depo-subQ in Uniject

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

U.S. FDA Resources

Further study details as provided by FHI 360:

Primary Outcome Measures:

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

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) [ 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


Enrollment:	476
Study Start Date:	July 2012
Study Completion Date:	April 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

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


Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667276

Locations


Senegal
Ministry of Health Clinics
All Cities Where There Is A Clinic, Senegal
Uganda
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

More Information

No publications provided by FHI 360

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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® 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® 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.


Responsible Party:	FHI 360
ClinicalTrials.gov Identifier:	NCT01667276 History of Changes
Other Study ID Numbers:	10196
Study First Received:	August 2, 2012
Last Updated:	July 16, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by FHI 360:


AE adverse event AIDS acquired immunodeficiency syndrome ALT (SGPT) alanine aminotransferase ART antiretroviral therapy AST (SGOT) aspartate aminotransferase DCF data collection forms DMC Data Monitoring Committee FDA (U.S.) Food and Drug Administration GCP Good Clinical Practice guidelines HB sAg Hepatitis B surface antigen ICH International Conference of Harmonisation	IND Investigational New Drug Application IRB Institutional Review Board IU international units mg milligram(s) mm3 cubic millimeter(s) PCR polymerase chain reaction SAE serious adverse event µg microgram ULN upper limit of the normal range WB Western Blot

ClinicalTrials.gov processed this record on February 27, 2015