Vaginal Ring Adherence in Sub-Saharan Africa: Expulsion, Removal, and Perfect Use

2020 ◽  
Author(s):  
Lungwani Muungo

In sub-Saharan Africa, HIV incidence andprevalence remain disproportionately high among women.Vaginal rings (VRs) have been formulated for the deliveryof antiretroviral-based microbicides, and their favorablesafety and tolerability profiles reported in clinical studies.Although the concept of drug release through a VR hasexisted since 1970, and VRs have been marketed since1992 for contraceptive or hormone replacement purposes,VR use as a microbicide delivery system is a novelapplication. This is the first study to evaluate VR adherenceamong African women in the context of its potential use asan HIV prevention method, to examine predictors ofadherence, and to describe clinical or contextual reasonsfor VR removals or nonadherence. This was a randomizedtrial of the safety and acceptability of a placebo VR wornfor 12 weeks in 170 HIV-negative, African women aged18–35 in four clinic sites in South Africa and Tanzania.The findings suggest that adherence to VR use in thecontext of HIV prevention trials in these communitiesshould be high, thereby enabling more accurate assessmentof an active microbicide safety and efficacy.Keywords Vaginal ring ? Adherence ? Sub-SaharanAfrica ? Female-controlled HIV prevention methods ?Microbicide delivery

2002 ◽  
Vol 13 (10) ◽  
pp. 657-666 ◽  
Author(s):  
David Gisselquist ◽  
Richard Rothenberg ◽  
John Potterat ◽  
Ernest Drucker

An expanding body of evidence challenges the conventional hypothesis that sexual transmission is responsible for more than 90% of adult HIV infections in Africa. Differences in epidemic trajectories across Africa do not correspond to differences in sexual behaviour. Studies among African couples find low rates of heterosexual transmission, as in developed countries. Many studies report HIV infections in African adults with no sexual exposure to HIV and in children with HIV-negative mothers. Unexplained high rates of HIV incidence have been observed in African women during antenatal and postpartum periods. Many studies show 20%–40% of HIV infections in African adults associated with injections (though direction of causation is unknown). These and other findings that challenge the conventional hypothesis point to the possibility that HIV transmission through unsafe medical care may be an important factor in Africa's HIV epidemic. More research is warranted to clarify risks for HIV transmission through health care.


Author(s):  
Neeraja Bhavaraju ◽  
Kathleen Shears ◽  
Katie Schwartz ◽  
Saiqa Mullick ◽  
Patriciah Jeckonia ◽  
...  

Abstract Purpose of review Clinical trials have found that the dapivirine vaginal ring (DVR) is safe to use and effective at reducing women’s risk of acquiring HIV infection. As countries prepare for the introduction of this novel long-acting, woman-controlled prevention method, an examination of key learnings from oral pre-exposure prophylaxis (PrEP) delivery will help programs leverage successful innovations and approaches to support DVR scale-up and expand the method mix for HIV prevention. Recent findings Intensive efforts over the past 5 years have yielded lessons on how to facilitate access to oral PrEP; expand service delivery for PrEP; address the knowledge, attitudes, and skills providers need to support PrEP initiation and effective use; develop messaging that builds community and partner support and combats stigma; and understand the cyclical nature of PrEP use. Summary Evidence from oral PrEP introduction and scale-up can help inform and expedite DVR introduction.


AIDS Care ◽  
2020 ◽  
Vol 32 (8) ◽  
pp. 1052-1060
Author(s):  
Calvin Mbeda ◽  
Arthur Ogendo ◽  
Richard Lando ◽  
David Schnabel ◽  
Deborah A. Gust ◽  
...  

2021 ◽  
Author(s):  
Margaret W. Gichane ◽  
◽  
Ariana W. K. Katz ◽  
Kenneth Ngure ◽  
Rachel Scheckter ◽  
...  

2020 ◽  
Author(s):  
Lungwani Muungo

BackgroundThis was the first microbicide trial conducted in Africa to evaluate an antiretroviral-containingvaginal ring as an HIV prevention technology for women.ObjectivesThe trial assessed and compared the safety, acceptability and adherence to product use ofa 4-weekly administered vaginal ring containing the antiretroviral microbicide, dapivirine,with a matching placebo ring among women from four countries in sub-Saharan Africa.Methods280 Healthy, sexually active, HIV-negative women, aged 18 to 40 years were enrolled with140 women randomised to a dapivirine vaginal ring (25 mg) and 140 women to a matchingplacebo ring, inserted 4-weekly and used over a 12-week period. Safety was evaluated bypelvic examination, colposcopy, clinical laboratory assessments, and adverse events.Blood samples for determination of plasma concentrations of dapivirine were collected atWeeks 0, 4 and 12. Residual dapivirine levels in returned rings from dapivirine ring userswere determined post-trial. Participant acceptability and adherence to ring use wereassessed by self-reports.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jonah Leslie ◽  
◽  
Flavia Kiweewa ◽  
Thesla Palanee-Phillips ◽  
Katherine Bunge ◽  
...  

Abstract Background Clinical trials have found that a monthly dapivirine vaginal ring was well-tolerated and reduced HIV-1 risk among women in sub-Saharan Africa. However, in order for the ring or other novel prevention methods to have optimal impact, it is necessary to understand and address women’s challenges to uptake and adherence. This paper provides insight into a few key challenges noted by women using the ring and contraceptives simultaneously. Methods The qualitative portion of the MTN-020/ASPIRE study consisted of data collection using single in-depth interviews, serial in-depth interviews, and focus group discussions, conducted with 214 participants across 15 sites in Malawi, South Africa, Uganda and Zimbabwe. A coding team used qualitative analysis software to identify themes within the interviews. Results The primary qualitative themes among participant data pertained to side effects. Participants reported negative side effects related to menses, in some cases attributing these effects to their contraceptives and in others to the vaginal ring. Participants also expressed concern over the long-term impact of contraception and ring use on fertility, including the reversibility of the contraceptive, especially among nulliparous women. Conclusions Women’s attitudes toward contraceptives can impact their willingness to concurrently use and adhere to a novel HIV prevention product. To optimize the potential of both prevention products, researchers should pre-emptively address concerns about contraceptive impact on fertility and counsel women about the expected side effects of contraceptives versus the ring. Clinical trials identifier NCT01617096. Registered on 6-12-2012 at clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT01617096


2013 ◽  
pp. 64-65
Author(s):  
Esper Kallas ◽  
Luiz Miraglia João

Two million two hundred thousand adults were newly HIV-infected in 2011, underscoring the urgent need for new, effective ways to prevent incident infections. Recently, the field of HIV prevention has gathered positive results from different strategies, among different populations, and with varying effect sizes, including the treatment of HIV-positive women and men in discordant couples, male circumcision of HIV-negative men in sub-Saharan Africa, a HIV vaccine evaluated in a community-based trial among HIV-negative men and women in Thailand, the use of vaginal gel formulation of TDF for HIV prevention in women in South Africa, pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF) or emtricitabine and TDF (TDF-FTC) among HIV-1-serodiscordant heterosexual couples from Kenya and Uganda, and PrEP with TDF-FTC among heterosexual men and women in Africa. Of these interventions, PrEP is an attractive policy because it does not directly interferes with the sexual intercourse, providing people a choice on HIV prevention regardless of cultural, religious, or social harnesses.


Author(s):  
Mariya V Sivay ◽  
Philip J Palumbo ◽  
Yinfeng Zhang ◽  
Vanessa Cummings ◽  
Xu Guo ◽  
...  

Abstract Background The HIV Prevention Trials Network (HPTN) 075 study evaluated the feasibility of enrolling and retaining men who have sex with men (MSM) and transgender women (TWG) from Kenya, Malawi, and South Africa. During the study follow-up, 21 participants acquired human immunodeficiency virus (HIV) (seroconverters). We analyzed HIV subtype diversity, drug resistance, transmission dynamics, and HIV superinfection data among MSM and TGW enrolled in HPTN 075. Methods HIV genotyping and drug resistance testing were performed for participants living with HIV who had viral loads >400 copies/mL at screening (prevalent cases, n = 124) and seroconverters (n = 21). HIV pol clusters were identified using Cluster Picker. Superinfection was assessed by a longitudinal analysis of env and pol sequences generated by next-generation sequencing. Results HIV genotyping was successful for 123/124 prevalent cases and all 21 seroconverters. The major HIV subtypes were A1 (Kenya) and C (Malawi and South Africa). Major drug resistance mutations were detected in samples from 21 (14.6%) of 144 participants; the most frequent mutations were K103N and M184V/I. Phylogenetic analyses identified 11 clusters (2–6 individuals). Clusters included seroconverters only (n = 1), prevalent cases and seroconverters (n = 4), and prevalent cases only (n = 6). Superinfections were identified in 1 prevalent case and 2 seroconverters. The annual incidence of superinfection was higher among seroconverters than among prevalent cases, and was higher than the rate of primary HIV infection in the cohort. Conclusions This report provides important insights into HIV genetic diversity, drug resistance, and superinfection among MSM and TWG in sub-Saharan Africa. These findings may help to inform future HIV prevention interventions in these high-risk groups.


2017 ◽  
Author(s):  
Irene Inwani ◽  
Nok Chhun ◽  
Kawango Agot ◽  
Charles M Cleland ◽  
Jasmine Buttolph ◽  
...  

BACKGROUND Sub-Saharan Africa is the region with the highest HIV burden. Adolescent girls and young women (AGYW) in the age range of 15 to 24 years are twice as likely as their male peers to be infected, making females in sub-Saharan Africa the most at-risk group for HIV infection. It is therefore critical to prioritize access to HIV testing, prevention, and treatment for this vulnerable population. OBJECTIVE Using an implementation science framework, the purpose of this research protocol was to describe the approaches we propose to optimize engagement of AGYW in both the HIV prevention and care continuum and to determine the recruitment and testing strategies that identify the highest proportion of previously undiagnosed HIV infections. METHODS We will compare two seek recruitment strategies, three test strategies, and pilot adaptive linkage to care interventions (sequential multiple assignment randomized trial [SMART] design) among AGYW in the age range of 15 to 24 years in Homa Bay County, western Kenya. AGYW will be recruited in the home or community-based setting and offered three testing options: oral fluid HIV self-testing, staff-aided rapid HIV testing, or referral to a health care facility for standard HIV testing services. Newly diagnosed AGYW with HIV will be enrolled in the SMART trial pilot to determine the most effective way to support initial linkage to care after a positive diagnosis. They will be randomized to standard referral (counseling and a referral note) or standard referral plus SMS text message (short message service, SMS); those not linked to care within 2 weeks will be rerandomized to receive an additional SMS text message or a one-time financial incentive (approximately US $4). We will also evaluate a primary prevention messaging intervention to support identified high-risk HIV-negative AGYW to reduce their HIV risk and adhere to HIV retesting recommendations. We will also conduct analyses to determine the incremental cost-effectiveness of the seek, testing and linkage interventions. RESULTS We expect to enroll 1200 participants overall, with a random selection of 100 high-risk HIV-negative AGYW for the SMS prevention intervention (HIV-negative cohort) and approximately 108 AGYW who are living with HIV for the SMART design pilot of adaptive linkage to care interventions (HIV-positive cohort). We anticipate that the linkage to care interventions will be feasible and acceptable to implement. Lastly, the use of SMS text messages to engage participants will provide pilot data to the Kenyan government currently exploring a national platform to track and support linkage, adherence to treatment, retention, and prevention interventions for improved outcomes. CONCLUSIONS Lessons learned will inform best approaches to identify new HIV diagnoses to increase AGYW’s uptake of HIV prevention, testing, and linkage to care services in a high HIV-burden African setting. CLINICALTRIAL ClinicalTrials.gov NCT02735642; https://clinicaltrials.gov/ct2/show/NCT02735642 (Archived by WebCite at http://www.webcitation.org/6vgLLHLC9)


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