A randomized controlled safety trial of the diaphragm and cellulose sulfate microbicide gel in sexually active women in Zimbabwe.

BACKGROUND: Cellulose sulfate (CS) is an antimicrobial and contraceptive agent. We assessed its safety when used alone or with the diaphragm in Harare, Zimbabwe. STUDY DESIGN: This was a randomized controlled safety trial with three arms: diaphragm with 6% CS gel vs. diaphragm with KY gel vs. CS gel alone. Participants were instructed to use their study products before every sex act for a period of 6 months. Safety end points were assessed monthly by questionnaires and urinanalysis and bimonthly by clinical examinations, colposcopy, wet mounts and gram stains. RESULTS: One hundred nineteen monogamous women were enrolled (28% HIV+) and 105 (88%) completed the study. No urinary tract infections were diagnosed during the study; 81.4% women had symptoms and/or signs of genital irritation considered at least possibly related to the gel or device, and 41.5% had changes in vaginal flora. There were no statistically significant differences between treatment groups in safety end points. All six women with deep epithelial disruption were diaphragm users, and all such findings were on the external genitalia. Of those, 4 had herpetic ulcers which were unrelated to products use. CONCLUSIONS: Cellulose sulfate appeared safe when used for 6 months alone or with a diaphragm

The Psychosocial Profile of Women Who Defaulted Option B+ HIV Treatment: An Interpretive Phenomenological Analysis Study

Purpose: The study explored the psychosocial profile of women who defaulted Option B+ HIV treatment at Chitungwiza Municipality clinics in Zimbabwe. Option B+ is a strategy to prevent mother-to-child transmission (PMTCT) of HIV to reduce MTCT rate to less than or equal to 5%. Methods: An interpretive phenomenological analysis (IPA) design was used. Data were collected from 04 September to 12 October 2020 on twelve purposively selected HIV-positive breastfeeding women aged 18 to 40 years, who defaulted Option B+ HIV treatment. Unstructured individual face-to-face interviews were utilised. Data were analysed thematically using the interpretive phenomenological analysis framework for data analysis. Results: The study findings revealed that participants experienced the following: psychosocial and emotional challenges due to HIV positive results, shown emotional distress and suicidal tendencies which affected their mental health. Their relationship was derailed due to abuse, infidelity, partner’s high-risk behaviour and to lack of support stemming from their partners and family members. Conclusion: Strengthening adherence support interventions and effective counselling on HIV-positive status disclosure and male partner involvement is important for retaining women in care and for improving their quality of life. Comprehensive, integrated, and tailor-made interventions should be adopted. Couple HIV counselling and testing should be encouraged. Psychosocial and mental health should be encouraged. Furthermore, community sensitization, risk reduction behaviour, education on purpose and side effects of ART as well as the benefits of Option B+ to new enrolments should be intensified and strengthened to minimize defaulting of treatment and LTFUP. Vigorous patient tracing and visit reminders help retain women in care.Health Studie