Clinical trial NCT01667276: Acceptability of Depo-subQ in Uniject
Official title: Acceptability of Depo-subQ in Uniject
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: PATH
First posted: 2012-08-17
Enrollment: 476
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
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

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.

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 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.

Primary outcomes:
measure: Measure the acceptability of Depo-subQ in Uniject among DMPA IM family planning clients;
timeFrame: 1 year
measure: 2) Measure the acceptability of Depo-subQ in Uniject among family planning providers (both clinic-based and CHWs);
timeFrame: 1 year
measure: Assess family planning providers' (clinic-based and CHWs) training materials.
timeFrame: 1 year
Secondary outcomes:
measure: 1) To qualitatively compare acceptability of Depo-subQ in Uniject among the two types of family planning providers-clinic-based and CHWs (Senegal only)
timeFrame: 1 year
measure: 2) To assess the safety of participants who receive Depo-subQ in Uniject during the study
timeFrame: 1 year
Other outcomes:
Locations:
city: All Cities Where There Is A Clinic
country: Senegal
facility: Ministry of Health Clinics
city: All Cities Where There Is A Clinic
country: Uganda
facility: Ministry of Health Clinics, Uganda
Study officials:
affiliation: FHI 360
name: Holly Burke, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of Health, Uganda
name: Anthony Mbonye, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division de la Sante de la Reproduction
name: Bpcar M Daff, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.