CompletedNot Applicable

Acceptability of Depo-subQ in Uniject

Senegal, Uganda476 participantsStarted 2012-07

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 year

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

Timeframe: 1 year

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

Timeframe: 1 year

Trial details

NCT IDNCT01667276

SponsorFHI 360

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-03

View on ClinicalTrials.gov More Contraception trials

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 1 year

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

Timeframe: 1 year

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

Timeframe: 1 year