Acceptability of Depo-subQ in Uniject

NCT01667276 | Completed

• 1 other identifier: 10196
• Study Type: observational
• Target: 476
• Locations: 2 countries
• Sites: 2

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.

Conditions

Contraception

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (2)

• 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

• 2) To assess the safety of participants who receive Depo-subQ in Uniject during the study

  1 year

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.

Sponsors & Collaborators

• FHI 360: lead
• United States Agency for International Development (USAID): collaborator
• PATH: collaborator

Study Sites (2)

Ministry of Health Clinics

All Cities Where There Is A Clinic, Senegal

Location

Ministry of Health Clinics, Uganda

All Cities Where There Is A Clinic, Uganda

Location

Related Publications (2)

• 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(R) 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.

  PMID: 24631328 DERIVED

• Burke HM, Mueller MP, Packer C, Perry B, Bufumbo L, Mbengue D, Daff BM, Mbonye A. Provider acceptability of Sayana(R) 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.

  PMID: 24576792 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 17, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 18, 2013

Record last verified: 2013-07

Locations

SE (1); UG (1)