Breaking News
April 18, 2019 - Hickenlooper Expanded Medicaid, Created State-Run Marketplace To Insure Nearly All Coloradans
April 18, 2019 - Cancer cells grown in tumor-mimicking environment can help predict the effect of experimental drugs
April 18, 2019 - Albireo Announces FDA Clearance of IND to Commence Phase 2 Trial of Elobixibat for the Treatment of NAFLD/NASH
April 18, 2019 - Adhesive gel bonds to eye surface, could repair injuries without surgery
April 18, 2019 - The future of genomics: A podcast featuring Stanford geneticists
April 18, 2019 - As Syphilis Invades Rural America, A Fraying Health Safety Net Is Failing To Stop It
April 18, 2019 - APOE gene impacts sleep depending on gender and severity of Alzheimer’s
April 18, 2019 - PCORI’s newly approved awards focus on cancer pain and opioid use disorders
April 18, 2019 - New tool provides a standard way to measure effects of caring for survivors of TBI
April 18, 2019 - Smartphone use risks eye examination misdiagnosis
April 18, 2019 - How drug-resistant bugs grow in CF patients’ lungs
April 18, 2019 - Gordana Vunjak-Novakovic Elected to American Academy of Arts & Sciences
April 18, 2019 - Podcast: KHN’s ‘What The Health?’ You Have Questions, We Have Answers
April 18, 2019 - Diabetic drug shows potential to be repurposed as heart disease treatment for non-diabetic patients
April 18, 2019 - New estimation method assesses natural variations in sex ratio at birth
April 18, 2019 - UTA scientist receives $1.17 million grant for cancer research
April 18, 2019 - Coagulation factor VIIa prevents bleeds in hemophilia animal models
April 18, 2019 - Researchers identify risk factors for severe infection after knee replacement
April 18, 2019 - Mass drug administration can offer community-level protection against malaria
April 18, 2019 - FDA’s added sugar label could have substantial health and cost-saving benefits
April 18, 2019 - Researchers identify cause of inherited metabolic disorder
April 18, 2019 - Single strip of white paint not sufficient to protect people who ride bikes
April 18, 2019 - Partner status influences link between sexual problems and self-efficacy in breast cancer survivors
April 18, 2019 - Colorectal Neoplasia Risk Up for Hodgkin Lymphoma Survivors
April 18, 2019 - Rigid spine muscular dystrophy – Genetics Home Reference
April 18, 2019 - Simple bile acid blood test could tell risk of stillbirth
April 18, 2019 - Center for Experimental Therapeutics aims to enable all steps of drug development | News Center
April 18, 2019 - Falling for telephone scams could be an early sign of dementia
April 18, 2019 - Researchers annotate key neuronal proteins in lamprey genome
April 18, 2019 - Study uncovers new biomarker for personalized cancer treatments
April 18, 2019 - Scientists enter research collaboration to find a cure for cancer
April 18, 2019 - Study to compare benefits of tai chi and mindfulness meditation on MS symptoms
April 18, 2019 - Gestational diabetes during pregnancy may increase risk of type 1 diabetes in children
April 18, 2019 - Is a New Remedy for Body Odor on the Horizon?
April 18, 2019 - Orthostatic hypotension – Genetics Home Reference
April 18, 2019 - Healing the heartbreak of stillbirth and newborn death
April 18, 2019 - Conference to highlight advances in human immune monitoring, bioinformatics | News Center
April 18, 2019 - Bacteria use viruses for self-recognition, study reveals
April 18, 2019 - New adhesive patch could help reduce post-heart attack muscle damage
April 18, 2019 - Researchers analyze the effects of dark play in a serious video game
April 18, 2019 - Scientists revive pig brain cells four hours after death
April 18, 2019 - Filial cannibalism and offspring abandonment may be forms of parental care
April 18, 2019 - Two proteins act in concert to maintain a healthy heart in mice, shows study
April 18, 2019 - Scientists create a functioning 3D printed heart
April 18, 2019 - Non-invasive vagus nerve stimulation improves disease symptoms in patients with rheumatoid arthritis
April 18, 2019 - Majority of men struggle to understand diagnosis and treatment of prostate cancer
April 18, 2019 - Researchers create new small molecules that may combat equine encephalitis viruses
April 18, 2019 - Animal-assisted therapy improves social behavior in patients with brain injuries
April 18, 2019 - Some viruses help protect harmful bacteria in CF patients | News Center
April 18, 2019 - Outpatient healthcare providers inappropriately prescribe antibiotics to 40% of patients
April 18, 2019 - Men who have a resting heart rate of 75 bpm are twice as likely to die early
April 18, 2019 - Novel serum biomarkers to detect NAFLD-related fibrosis
April 18, 2019 - New study delves deeper into individual genomic differences than ever before
April 18, 2019 - Gilead and Galapagos Announce Filgotinib Meets Primary Endpoint in the Phase 3 FINCH 3 Study in Methotrexate-Naïve Rheumatoid Arthritis Patients
April 18, 2019 - Emotional mirror neurons found in rats
April 18, 2019 - Sylvia Plevritis appointed chair of biomedical data science | News Center
April 18, 2019 - Cervical cancer subtype increasing in several subpopulations of women
April 18, 2019 - Yeast strain provides manufacturing boost to low-calorie sweetener derived from lactose
April 18, 2019 - One in five children and youth suffer from a mental disorder
April 18, 2019 - Improper inhaler use common in children with asthma
April 18, 2019 - C-Path and CDISC release global Therapeutic Area Standard for HIV research
April 18, 2019 - Integrating AI to analyze imaging data allows early recognition of heart disease
April 18, 2019 - Low-cost, high-speed algorithm may allow animal-free chemical toxicity testing
April 18, 2019 - HPV-negative cervical cancers are more aggressive with worse prognosis
April 18, 2019 - AI detects prostate cancer with same level of accuracy as experienced radiologists
April 18, 2019 - Study resolves sex differences in psychiatric illness risk
April 18, 2019 - Novartis Announces FDA Filing Acceptance and Priority Review of Brolucizumab (RTH258) for Patients with Wet AMD
April 18, 2019 - Cocktail of common antibiotics can fight resistant E. coli
April 18, 2019 - Persis Drell to give keynote address at medical school diploma ceremony | News Center
April 18, 2019 - EpicTogether: Remembering Our Why
April 18, 2019 - Study identifies novel loci contributing to asthma susceptibility in adults
April 18, 2019 - Gut bacteria and pregnancy
April 18, 2019 - New study finds that screening could help prevent rare types of cervical cancer
April 17, 2019 - Spatial orgnization of the genome can be altered using small molecules
April 17, 2019 - AEDs Tied to Higher Pneumonia Risk in Alzheimer Patients
April 17, 2019 - Telemedicine tied to more antibiotics for kids, study finds
April 17, 2019 - Two medical students awarded 2019 Soros Fellowships for New Americans | News Center
April 17, 2019 - Sociologist Constance A. Nathanson Awarded Guggenheim Fellowship
April 17, 2019 - Empathy and hormones could account for aggressive behavior in children, shows study
April 17, 2019 - Researchers develop oral appliance to help sufferers of sleep apnea
MTN launches new study to empower teen girls with choices in HIV prevention

MTN launches new study to empower teen girls with choices in HIV prevention

image_pdfDownload PDFimage_print

AIDS is already the leading cause of death among girls and young women in much of Africa, and matters could only get worse, given that for every day that passes, 1,000 more girls ages 15 to 24 are likely to become infected with HIV.

Ensuring that women and girls can have access to and benefit from safe and effective methods of prevention is imperative, say researchers from the National Institutes of Health (NIH)-funded Microbicide Trials Network (MTN) who have launched a new study called REACH and enrolled its first participant.

In REACH (Reversing the Epidemic in Africa with Choices in HIV prevention), or MTN-034, researchers are focusing on two methods they believe could make a difference for many young women – a daily oral tablet called Truvada®, an approach often referred to as PrEP, short for pre-exposure prophylaxis, which is now approved in many countries; and a monthly vaginal ring containing an antiretroviral (ARV) drug called dapivirine currently undergoing regulatory review.

If approved, the dapivirine ring would be the first biomedical prevention method specifically for women, i.e., for women 18 and older. Additional information about the vaginal ring in girls under age 18, particularly about its safety, would be required before regulatory bodies would consider expanding approval to include a younger population.

REACH is a Phase IIa study that is designed to fill important gaps in information about the safety and acceptability of the dapivirine ring and oral PrEP, including in girls as young as 16. REACH also seeks to understand what young women will need to help them to use these products. Each must be used consistently and regularly to be effective – daily for oral PrEP, and monthly for the ring – which has been a challenge for younger women in clinical trials.

“With PrEP being made available in many countries and the possibility that the ring will be approved, we want to see that these products can work for and be made available to women and girls of all ages at risk of HIV acquisition, who both need and deserve methods of protection that are in their control,” noted Lulu Nair, MBChB, MPH, protocol chair of the REACH study, who is clinical research site leader at the Desmond Tutu HIV Centre (DTHC), University of Cape Town, in Cape Town, South Africa.

REACH will enroll 300 young women and girls ages 16 to 21 at five MTN-affiliated clinical research sites in Kenya, South Africa, Uganda and Zimbabwe. Two of the sites have begun the study: the Makerere University-Johns Hopkins University Research Collaboration in Kampala, Uganda, where the first participant was enrolled, and the University of Zimbabwe College of Health Sciences Spilhaus Clinical Research Site in Harare.

All participants in REACH will use oral PrEP and the dapivirine ring, each for six months. After experiencing both approaches, participants will have a choice of using either the ring or PrEP – or neither – for an additional six months. REACH is expected to take about three years to conduct, with results anticipated in late 2022 or early 2023.

MTN researchers have already conducted a safety study of the dapivirine ring in the United States that enrolled 96 girls ages 15-17 who were randomly assigned to use the dapivirine ring or a placebo ring for a month at a time for a total of six months. Results of this study, referred to as MTN-023 /IPM 030, were reported in 2017 and found the ring was well-tolerated and acceptable. Adherence was also high – 95 percent of the rings returned after use had drug levels indicating consistent use during the previous month.

The dapivirine ring was well-tolerated and reduced the risk of HIV in two Phase III trials that together enrolled more than 4,500 women ages 18-45 from four African countries – ASPIRE , which was conducted by the MTN, and The Ring Study, led by the International Partnership for Microbicides (IPM), a non-profit organization that developed the dapivirine ring and is seeking its regulatory approval.

Yet, in ASPIRE, the dapivirine ring was not effective among younger women ages 18-21, who used the monthly ring least regularly. Similar results were seen among 18- to 21-year-old women in The Ring Study. Likewise, in studies with oral PrEP, it has been the younger participants who have struggled most with a daily pill-taking regimen. Results of a study, called HPTN 082, expected later this year, will shed additional light about PrEP use among girls ages 16-25 in South Africa and Zimbabwe.

As part of REACH, participants will receive extensive support and counseling focused on product adherence. They also will be encouraged to be open with study staff about any concerns or difficulties they may have.

“We have incorporated a number of supportive measures to help with adherence in REACH, but if girls aren’t willing or able to use the ring or PrEP, we want to understand why, so that we can learn what is needed to better support use,” explained Kenneth Ngure, Ph.D., M.P.H., associate professor and chair of the department of community health at Jomo Kenyatta University of Agriculture & Technology in Nairobi, Kenya, and REACH protocol co-chair. “At the same time, it’s important to recognize that these products won’t be for everyone, and the reasons why are just as important for us to understand.”

“Women need HIV prevention methods that are under their control, and their needs and preferences may change,” added Connie Celum, M.D., M.P.H., who is also a protocol co-chair, and professor of global health and medicine and director, International Clinical Research Center at the University of Washington in Seattle. “That’s why having different HIV prevention methods is so important, and why we have incorporated choice into the design of this study. It’s really quite exciting that we have come this far, to having PrEP, but also potentially the dapivirine ring.”

If approved, the ring could be available in some countries as early as 2020.

“Girls have told us that being able to protect themselves from HIV would be empowering, and that having choice would be especially empowering. They want and deserve to have control of their health, their lives and their destinies,” said Sharon Hillier, Ph.D., MTN principal investigator and professor and vice chair of the department of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh School of Medicine and Magee-Womens Research Institute.

In addition to the sites in Uganda and Zimbabwe, REACH will be conducted in Kisumu, Kenya at the Kenya Medical Research Centre (KEMRI) Centre for Global Health; and in South Africa at the DTHF’s Emavundleni Research Centre in Cape Town and the Wits Reproductive Health and HIV Institute in Johannesburg.

According to UNAIDS, young women comprised 26 percent of new HIV infections in eastern and southern Africa in 2017, despite making up only 10 percent of the population. Many factors may contribute to HIV susceptibility in adolescent girls and young women, including gender-based violence, cultural and economic inequities and biological or hormonal changes.

As a global priority, young women and girls need safe and effective biomedical HIV prevention strategies for use throughout their lifespan, including during times of pregnancy and breastfeeding, when the risk of infection is estimated to be three to four times greater than when not pregnant or nursing. Similar to REACH, the MTN is planning studies of the monthly dapivirine ring and oral PrEP in pregnant women (MTN-042, or the DELIVER Study) and breastfeeding women and infants (MTN-043, or B-Protected).


Tagged with:

About author

Related Articles