HIV Infections Clinical Trial
Official title:
Cluster Randomized Trial of Integration of Family Planning Services Into HIV Care and Treatment in Suba, Kisumu East, Rongo and Migori Districts of Nyanza Province
This is a cluster randomized trial comparing the integration of family planning services into HIV care and treatment programs versus the standard referral for family planning services outside of HIV care and treatment programs within Suba, Kisumu East, Rongo and Migori districts in Nyanza province.
Status | Completed |
Enrollment | 5040 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: For health facilities: - Each site must be providing HIV care and treatment services For participants: - Women aged 18-45, not pregnant, HIV+, receiving HIV care at that health facility - Men aged 18 and above, HIV+, receiving HIV care at that health facility Exclusion Criteria: For health facilities - If they do not meet the inclusion criteria listed above - If they are already providing integrated comprehensive HIV care and treatment that includes on-site family planning counseling and provision For participants: - Participants are excluded if they do not meet the inclusion criteria listed above. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Kenya | Migori District Hospital | Migori |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Bill and Melinda Gates Foundation, Ibis Reproductive Health, Kenya Medical Research Institute, Tides |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence More Effective Contraception (defined as hormonal methods, intrauterine devices, and permanent methods) | 1 year post integration/site initiation and 2 years post integration/site initiation | No | |
Primary | Pregnancy rate | 1 year post integration/study initiation and 2 years post integration/site initiation | No | |
Secondary | Knowledge of contraceptive methods among HIV-positive women | baseline (months 1-3); post-intervention (months 9-12) | No | |
Secondary | Knowledge of contraceptive methods among providers | baseline (months 1-3); post-intervention (months 9-12) | No | |
Secondary | Acceptability of family planning services | baseline (months 1-3); post-intervention (months 9-12) | No | |
Secondary | Feasibility of providing family planning services at HIV care and treatment centers | months 9-12 | No | |
Secondary | Reproductive intentions of HIV-infected women receiving care and treatment | months 1-3 | No |
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