About the study (objectives)
This study will test the effectiveness of acetylsalicylic acid (ASA; Aspirin) in reducing immune activation and number of HIV target cells in the genital tract in female sex workers in Nairobi, Kenya.
About the disease/condition (background/context)
Research with sex workers in Kenya has found that there are people with a natural protection against HIV, meaning they can be exposed to HIV without acquiring the virus. This natural protection seems to be related to a lower overall level of immune activation as well has having fewer HIV target cells (CD4+ CCR5+ T cells) in the genital tract.
Previous research has also shown that common anti-inflammatory drugs may be able to decrease the number of HIV target cells in the female genital tract. CTN 316 will test two doses of ASA to determine the impact on target cells and to provide information needed to conduct a larger study that will focus on the number of new HIV cases. The study will be conducted in Kenya with female sex workers because their immune profiles differ from non-sex workers and, if found to be effective, ASA could be a valuable preventative treatment in this population.
Study Approach (methodology)
Through ongoing consultation with peer leaders in the female sex worker community, the study team will recruit 300 women to participate in the study. Study participants will be randomized to take either 100 mg ASA, 300 mg ASA, or placebo daily over a 6-month period. Study participation will not affect the regular care received at the clinic.
Cervical and vaginal samples, blood draws, and urine samples will be provided by participants at baseline and at 1-month intervals throughout the study period. Following six months of treatment, participants will return within four weeks for safety monitoring. The data will be analyzed to determine the differences in immune activation and genital environment between the three study arms.
- Older than 18 years of age and less than 55
- Active in sex work for five years or less
- Uterus and cervix present
- Willing to take daily study drug (acetylsalicylic acid)
- Willing to undergo pelvic exams
- No chronic infection or cardiovascular disease and not taking any anti-inflammatory or immunosuppressants
- HIV negative
- Currently breast feeding
- Pregnancy (if a woman becomes pregnant during the study she will be removed)
- Pregnant in the last 12 months
- Presence of sexually transmitted infections or bacterial vaginosis at enrollment
- Not involved in sex work or being involved in sex work for more than 6 years
- Consumption of specific medications that would interfere with the study drug
- Allergy to acetylsalicylic acid, other medication for pain or fever, tartrazine or other medication
- Chronic diseases, 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
- History of a diagnosed cardiovascular event, heart failure, peripheral arterial disease, angina, stoke, transient ischemic attack
- Current or recurrent condition with a high risk of major bleeding
- Current participation in another clinical trial
Sex Worker Outreach Program (SWOP) Clinics
Nairobi County, Kenya
For more information about the study, please contact the principal investigator.
Dr. Keith Fowke
University of Manitoba