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Completed

NCT Number: NCT01667276

Acceptability of Depo-subQ in Uniject

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.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

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

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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. 2) Measure the acceptability of Depo-subQ in Uniject among family planning providers (both clinic-based and CHWs);

    Time frame: 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

  3. Assess family planning providers' (clinic-based and CHWs) training materials.

    Time frame: 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 outcomes

  1. 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

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

    Time frame: 1 year

    frequencies of reported adverse events by country

Sponsors and collaborators

Lead sponsor

FHI 360

Other

Collaborators

  • PATH
  • United States Agency for International Development (USAID)

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 17, 2012
Registry last updated
Jul 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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