HIV/AIDS
Conditions
Interventions
Group A
Group B
Group C
Sponsors
Medical Research Council
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women aged 18 years and above at enrolment Likely to be sexually active at entry and during follow-up Willing to use study gel as instructed Willing to return applicators every week day Willing to attend the clinic every 4 weeks and be interviewed Willing to be followed up and interviewed if she defaults Willing to receive health education about condoms Willing to undergo pregnancy tests on a monthly basis Willing and able to give informed consent
Exclusion criteria
Exclusion criteria: Using a product in a trial, or otherwise e.g. licensed spermicide, that is likely to impact on the outcome of this study and she is unwilling to stop use for the duration of study Unable to agree a reliable method of contact with the field team Likely to move out of the area within the next 3 months Pregnant (including positive pregnancy test at enrolment) Has clinical condition considered by the study management group to make enrolment inadvisable Considered by the study personnel to be unlikely to be able to comply with the study procedures Previously enrolled on MDP301 trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence to daily use of gel | — |
Secondary
| Measure | Time frame |
|---|---|
| Consistency of adherence measure;Retention;Reasons for non-adherence | — |
Countries
Mozambique, South Africa, Tanzania, Uganda, Zambia
Contacts
Public ContactLisa Burch
Trial Manager
Outcome results
None listed