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The proposed study is a multi-centre, open-label crossover study to assess the safety and acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a 12 week period in 200 healthy, sexually active women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | vaginal ring first 12 weeks & observational safety last 12 weeks |
|
| B | Experimental | observational safety first 12 weeks & vaginal ring last 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravaginal ring | Device | silicone elastomer intravaginal ring containing no drug product |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary measure of acceptability will be defined as the proportion of women indicating that they would use the study product if it is found to prevent HIV. | 3 months | |
| The primary measure of safety will be the proportion of women who have abnormal observations during the pelvic/speculum examinations and the proportion of women who experience adverse events | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Annalene Nel | Beijing Immupeutics Medicine Technology Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Health & HIV Research Unit - Sheshisani IPM Clinic | Yeoville | Johannesburg | South Africa | |||
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| South African Medical Research Council |
| Durban |
| KwaZulu-Natal |
| 4067 |
| South Africa |
| Desmond Tutu HIV Foundation, Masiphumelele | Cape Town | 7975 | South Africa |
| Kilimanjaro Reproductive Health Program | Moshi | Tanzania |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |