Browsing by Author "Naidoo, Logashvari"

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    Dapivirine vaginal ring use does not diminish the effectiveness of hormonal contraception
    (Journal of acquired immune deficiency syndromes, 2017) Balkus, Jennifer E.; Palanee-Phillips, Thesla; Reddy, Krishnaveni; Siva, Samantha; Harkoo, Ishana; Nakabiito, Clemensia; Kintu, Kenneth; Nair, Gonasangrie; Chappell, Catherine; Matovu Kiweewa, Flavia; Kabwigu, Samuel; Naidoo, Logashvari; Jeenarain, Nitesha; Marzinke, Mark; Soto-Torres, Lydia; Brown, Elizabeth R.; Baeten, Jared M.
    To evaluate the potential for a clinically relevant drug-drug interaction with concomitant use of a dapivirine vaginal ring, a novel antiretroviral-based HIV-1 prevention strategy, and hormonal contraception by examining contraceptive efficacies with and without dapivirine ring use. A secondary analysis of women participating in MTN-020/ASPIRE, a randomized, double-blind, placebo-controlled trial of the dapivirine vaginal ring for HIV-1 prevention. Methods: Use of a highly effective method of contraception was an eligibility criterion for study participation. Urine pregnancy tests were performed monthly. Pregnancy incidence by arm was calculated separately for each hormonal contraceptive method and compared using an Andersen-Gill proportional hazards model stratified by site and censored at HIV-1 infection. Of 2629 women enrolled, 2310 women returned for follow-up and reported using a hormonal contraceptive method at any point during study participation (1139 in the dapivirine arm, 1171 in the placebo arm). Pregnancy incidence in the dapivirine arm versus placebo among women using injectable depot medroxyprogesterone acetate was 0.43% vs. 0.54%, among women using injectable norethisterone enanthate was 1.15% vs. 0%, among women using hormonal implants was 0.22% vs. 0.69%, and among women using oral contraceptive pills was 32.26% vs. 28.01%. Pregnancy incidence did not differ by study arm for any of the hormonal contraceptive methods. Use of the dapivirine ring does not reduce the effectiveness of hormonal contraceptives for pregnancy prevention. Oral contraceptive pill use was associated with high pregnancy incidence, potentially due to poor pill adherence. Injectable and implantable methods were highly effective in preventing pregnancy.
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    High recent PrEP adherence with point-of-care urine tenofovirtesting and adherence counselling among young African women:results from the INSIGHT cohort
    (John Wiley and Sons Inc, 2024-12) Gati Mirembe, Brenda; Donnell, Deborah; Krows, Meighan; Zwane, Zinhle; Bukusi, Elizabeth; Panchia, Ravindre; Louw, Cheryl; Mwelase, Noluthando; Selepe, Pearl; Senne, Melissa; Naidoo, Logashvari; Chihana, Rachel; Kasaro, Margaret; Nuwagaba-Biribonwoha, Harriet; Kotze, Philip; Gill, Katherine; MacDonald, Pippa; vanHeerden, Alastair; Bosman, Shannon; Jaggernath, Manjeetha; du Preez, Phillip; Ward, Amy; Peters, Remco P H; Delany-Moretlwe, Sinead; Et.al
    Adolescent girls and young women (AGYW) account for two-thirds of new HIV infections in Africa. African AGYW have had high uptake of oral HIV pre-exposure prophylaxis (PrEP) but low adherence, which might be improved by point-of-care adherence monitoring with tailored counselling. From August 2022 to July 2023, we conducted a PrEP demonstration project with sexually active AGYW ages 16-30 years from 20 sites in South Africa, Eswatini, Kenya, Malawi, Uganda and Zambia. Participants were offered oral tenofovir-based PrEP at enrolment and followed up at 1, 3 and 6 months. PrEP adherence was assessed by a point-of-care qualitative lateral flow urine tenofovir (TFV) assay indicating PrEP use in the prior 4 days, which accompanied real-time adherence counselling that incorporated urine TFV results when testing was available (70.8% of month 1, 35.3% of month 3 and 83.9% of month 6 visits). We estimated overall adherence, correcting for missing test results, and analysed the association of having received urine TFV results at month 1 or 3 with subsequent urine TFV test positivity, using modified Poisson regression. Of the 3087 AGYW enrolled, the median age was 24 years (interquartile range 21-27), 75.7% were from South Africa, 2878 (93.2%) initiated PrEP at enrolment and 107 (3.5%) after enrolment. Visit retention was 92.0-96.2% for months 1, 3 and 6, and 2518 (90.1%) exited the study with a PrEP refill. Adherence, based on the point-of-care urine tenofovir test positivity rate, was estimated as 72%, 71% and 65% at months 1, 3 and 6, respectively. Women who received one prior urine TFV test had a 42% higher likelihood of a subsequent positive urine TFV test (adjusted odds ratio, OR = 1.42, 95% confidence interval, CI 1.27-1.60), and those having received two prior tests had a 67% higher likelihood (adjusted OR = 1.67; 95% CI 1.41-1.98). Observed HIV incidence was 1.38/100 person-years (95% CI 0.97-2.08). Oral PrEP uptake, recent adherence and persistence were high in a multisite cohort of young African women over 6 months of follow-up. The use of a novel point-of-care tenofovir assay with tailored real-time adherence counselling was associated with increased adherence to PrEP at subsequent visits, warranting further study. clinicaltrials.gov NCT05746065.
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    The Influence of Perceived Dapivirine Vaginal Ring Effectiveness on Social Disclosure and Ring Adherence
    (AIDS and Behavior, 2013) Stoner, Marie C. D.; Brown, Elizabeth R.; Palanee‑Phillips, Thesla; Mansoor, Leila E.; Tembo, Tchangani; Nair, Gonasagrie; Akello, Carolyne; Seyama, Linly; Jeenarain, Nitesha; Naidoo, Logashvari; Mgodi, Nyaradzo; Hunidzarira, Portia; Chitukuta, Miria; Straten, Ariane van der
    We analyzed data from 1428 users of the dapivirine vaginal ring, who participated in the MTN-020/ASPIRE phase III trial and subsequent open-label extension MTN-025/HOPE trial, to examine relationships between perceived ring protection, social disclosures, and self-reported ring adherence. In HOPE, 77% perceived the ring to be highly effective, and this view was associated with speaking: (a) to a greater number of people about the study, (b) with other participants, (c) to more people who were in favor of the ring, and (d) to more people whose opinions were valued. Reported adherence was not directly associated with perceived protection but was associated with disclosing to someone who was in favor of the ring. These findings suggest the importance of women’s internalized ideas about the protective benefits of the DVR in sharing information about the ring and the importance of social support on adherence
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    Social harms in female-initiated HIV prevention method research: state of the evidence
    (AIDS (London, England), 2019) Montgomerya, Elizabeth T.; Robertsa, Sarah T.; Nelb, Annalene; Malherbeb, Mariette; Torjesenc, Kristine; Bunged, Katherine; Singhd, Devika; Baetene, Jared M.; Marrazzof, Jeanne; Chirenjeg, Z. Mike; Kabwigu, Samuel; Beigi, Richard; Riddler, Sharon A.; Gaffour, Zakir; Reddy, Krishnaveni; Mansoor, Leila E.; Nair, Gonasagrie; Woeberi, Kusbashni; Moodley, Jayajothi; Jeenaraini, Nitesha; Siva, Samantha; Naidoo, Logashvari; Govender, Vaneshree; Palanee-Phillips, Thesla
    Assessment of safety is an integral part of real-time monitoring in clinical trials. In HIV prevention research, safety of investigational products and trial participation has been expanded to include monitoring for ‘social harms’, generally defined as negative consequences of trial participation that may manifest in social, psychological, or physical ways. Further research on social harms within HIV prevention research is needed to understand the potential safety risks for women and advance the implementation of prevention methods in real-world contexts. Secondary analysis of quantitative data from three randomized, double-blind, placebo-controlled trials of microbicide candidates in sub-Saharan Africa was conducted. Additionally, we assessed data from two prospective cohort studies that included participants who became HIV-positive or pregnant during parent trials.