Reducing HIV risk in female sex workers using ASA
Preventing HIV Infection by Targeting the Immune System Instead of the Virus
This study is testing if a common pain reliever can help reduce the risk of HIV in young female sex workers in Nairobi by changing their immune response.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Manitoba Academic / other |
| Locations | 1 site (Nairobi,) |
| Trial ID | NCT03629327 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the potential of acetylsalicylic acid (ASA) in inducing a unique immune response known as Immune Quiescence in the female genital tract of sex workers in Nairobi, Kenya. By understanding how this immune phenotype can lower the number of HIV target cells, the researchers hope to develop new preventive strategies against HIV transmission. Participants will be given different formulations of ASA to determine the most effective dosage for reducing HIV susceptibility. The study focuses on women who have been active in sex work for five years or less and are HIV negative.
Who should consider this trial
Good fit: Ideal candidates for this study are female sex workers aged 18 to 45 who have been active in sex work for five years or less and are HIV negative.
Not a fit: Patients who are older than 45, pregnant, breastfeeding, or have chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to innovative preventive measures that empower women to protect themselves against HIV infection.
How similar studies have performed: Previous pilot studies have shown promise in using anti-inflammatory drugs to reduce HIV target cells, suggesting that this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age greater of 18 years and less than 45 * Be active in sex work for five years or less * Uterus and cervix present * Willing to take daily the study drug (acetylsalicylic acid) * Willing to undergo pelvic exams * In general good health, no chronic infection and not taking any anti-inflammatory or immunosuppressors * Being HIV negative * Without any cardiovascular disease Exclusion Criteria: * Age less than 18 or more than 45 * Breastfeeding * Pregnant in the last 12 months * Presence of sexual transmissible disease or bacterial vaginosis at enrollment * Menopausal * Pregnancy (if a women becomes pregnant during the study she will be excluded) * Not being involve in sex work or being involved in sex work for more than 6 years * Having a chronic disease * Consumption of the medication listed in appendix entitled: list of other medication for health conditions * Being allergic to acetylsalicylic acid, other medication for pain or fever, tartrazine or any other medication * Having heartburn, stomach pain, stomach ulcer, anemia, hemophilia, kidney or liver disease, psoriasis, porphyria or other blood disease, G-6-PD deficiency, dermatitis (skin inflammation), alcoholism * Having a history of a diagnosed cardiovascular event, heart failure, peripheral arterial disease, angina, stoke, transient ischemic attack * Having a current or recurrent condition with a high risk of major bleeding * Having anemia * Current participation in a clinical trial
Where this trial is running
Nairobi,
- Kenyan Aids Control Project/University of Nairobi — Nairobi,, Kenya (Recruiting)
Study contacts
- Study coordinator: Keith R Fowke, PhD
- Email: keith.fowke@umanitoba.ca
- Phone: 204-789-3296
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.