Acceptability of Depo-subQ in Uniject
Condition: Contraception
Study type: Observational

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.
    

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
    

Time perspective: Prospective
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
      
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