Samuel Kabwigu1, Lisa Noguchi2, Jothi Moodley3, Thes Pala- nee4, Kenneth Kintu1 ... Johns Hopkins University, Baltimore MD USA, Baltimore,. MD, United ...
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P45.05 The MTN-016 Pregnancy Registry: Baseline Characteristics of Enrollees from the VOICE Study and Reasons for Non-enrollment of Eligible Women
Kenya Medical Research Institute - CIPDCR, Busia, Kenya, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya, 3Kenya Medical Research Institute - CIPDCR/ Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya
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Samuel Kabwigu1, Lisa Noguchi2, Jothi Moodley3, Thes Palanee4, Kenneth Kintu1, Lulu Nair5, R Panchia6, Pearl Selepe7, Jennifer E. Balkus8, Kristine Torjesen9, Jeanna Piper10, Rachel Scheckter9, Rohan Hazra11, Richard Beigi12 1
MU-JHU Research Collaboration, Kampala, Uganda, 2MTN/ Johns Hopkins University, Baltimore MD USA, Baltimore, MD, United States, 3MRC, Durban, South Africa, 4Wits Reproductive Health & HIV Institute, Johannesburg, South Africa, 5 CAPRISA, Durban, South Africa, 6PHRU, Soweto, South Africa, 7Aurum Institute, Klerksdorp, South Africa, 8FHCRC and University of Washington, Seattle WA, WA, United States, 9 FHI 360, Durham, NC, United States, 10US NIH/DAIDS, Bethesda, MD, United States, 11US NIH/NICHD, Bethesda, MD, United States, 12University of Pittsburgh/Magee-Womens Hospital, Pittsburgh, PA, United States Background: As pregnant women are at risk for HIV and women at risk of HIV may become pregnant, it is important to assess the safety of candidate HIV prevention products in both non-pregnant and pregnant women. Methods: The MTN-016 pregnancy registry is a prospective observational cohort in which participants who became pregnant during MTN effectiveness studies or those with planned exposures in pregnancy safety studies are monitored for adverse obstetric outcomes; infants from these pregnancies are followed through the first year of life. Registry enrollment systematically excludes termination of pregnancy and early pregnancy loss, including early non-viable pregnancies with a transient positive test at a monthly visit, as these data are captured in parent protocols. For VOICE participants enrolled into the registry from Uganda, Zimbabwe and South Africa, we describe baseline demographic characteristics and key reasons for non-enrollment as reported by site investigators. Results: Among 5029 VOICE participants with over 5425 person-years (py) of follow-up, there were 424 pregnancies (7.8/100 py) and 201 live births. Of these pregnancies, 261 (62%) were eligible for MTN-016. The average age of women who became pregnant during VOICE was 24, with 24% of women married at baseline. Of these, 213/261 (82%) women and 185/201 (92%) of their infants enrolled in MTN-016 (average maternal age 25 years, 33% married). Reasons for non-enrollment of eligible participants into MTN-016 included additional study visit burden and employment. Cultural customs related to temporary relocation to rural areas during the postnatal period and the limitation of public access to newborns were also cited as barriers to enrollment. Conclusions: In this pregnancy exposure registry for candidate HIV prevention agents, the majority of eligible women from VOICE and their infants were enrolled. Study visit burden and local cultural customs may impact the enrollment of mothers and their infants into a pregnancy registry protocol.
Background: Although ARVs and public awareness is being used to eliminate new HIV infections among infants, limited information indicating their impact on the trend of HIV prevalence among infants born to HIV infected mothers exists. This study determined the trend of HIV infection among infants born to HIV infected mothers in relation to specific ARV administration. Also assessed the knowledge about HIV transmission between mothers and infants. Methods: In a cross-sectional study, dried blood spot samples (2010, n = 4210; 2011, n = 4093; 2012, n = 4686; 2013, n = 3080) collected from infants aged £ 18 months. These samples were analyzed at KEMRI-CIPDCR using PCR assay. Some mothers who received public health education were pregnant. All mothers were put on anti-retroviral drugs during and after delivery. Results: Out of the total number of samples tested 9.7%; 8.5%; 7.9%; 7.2% were HIV positive in 2010; 2011; 2012; 2013 respectively. The prevalence of HIV in infants whose mothers had been put on ARVS was as follows: AZT + NVP + 3TC was 10.4%, 9.1%, 6.3%, 6.0% in 2010; 2011; 2012, 2013 respectively. HAART was 7.1%; 6.1%; 4.7%; 3.9% in 2010; 2011; 2012, 2013 respectively. SdNVP was 10.3%; 7.4%; 6.2%; 6.0% in 2010; 2011; 2012; 2013 respectively. Those mothers who had not been given any ARV had their infants with HIV prevalence reaching 11.2%; 12.6%; 12.7%; 12.9% in 2010; 2011; 2012; 2013 respectively. Those mothers who were aware that ARVs reduce transmission of HIV from mother to child were 30%vs70%; not breastfeeding were 37%vs81% and Delivery at the hospital were 43%vs89% before and after public health awareness respectively. Conclusions: Direct relationship between specific ARV administration and HIV infection among infants exists. This is evident by the fact that HIV prevalence appeared to decrease with subsequent years of provision of specific drugs. HAART seemed to provide greater impact in HIV prevention compared to others. There is need for intensified awareness among reproductive women to help in reduction of transmission.
P45.07 Obstetric and Infant Outcomes Following Planned Maternal Third Trimester Exposure to Tenofovir 1% Vaginal Gel Lisa M. Noguchi1,2, Joseph Biggio3, Katherine Bunge2,4, James Dai5, Karen Isaacs6, Kristine Torjesen6, Samuel Kabwigu7, Jill Schwartz8, Juan Vargas9, Fernando Scaglia10, Cindy Jacobson2, D H. Watts11, Jeanna M. Piper12, Richard H. Beigi2,4, for the MTN-002, MTN-008 & MTN-016 (EMBRACE) Study Teams 1
P45.06 Impact of ARVs and Public Health Awareness on the Trend of HIV Infections among Infants Born to HIV Infected Mothers Olipher Makwaga1, Anne Muigai2, Freda Andayi1, Tom Mokaya1, Matilu Mwau3
Johns Hopkins Bloomberg School of Public Health, Epidemiology, Baltimore, MD, United States, 2Microbicide Trials Network, Pittsburgh, PA, United States, 3University of Alabama at Birmingham, Birmingham, AL, United States, 4University of Pittsburgh/Magee-Womens Hospital, Pittsburgh, PA, United States, 5Statistical Center for HIV/AIDS Research and Prevention, Seattle, WA, United States, 6FHI 360, Durham, NC, United States, 7MU-JHU Research Collaboration, Kampala, Uganda, 8 CONRAD/EVMS, Arlington, VA, United States, 9San Francisco
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General Hospital/UCSF School of Medicine, San Francisco, CA, United States, 10Baylor College of Medicine, Houston, TX, United States, 11Office of the Global AIDS Coordinator, U.S. Dept. of State, Washington, DC, United States, 12US NIAID/ Division of AIDS, Bethesda, MD, United States Background: Thorough drug safety evaluation includes assessing potential impact of use on obstetric (OB) and infant outcomes. The MTN-016 study is the first pregnancy exposure registry for anti-HIV PrEP and microbicide agents. We evaluated OB and infant outcomes for registrants enrolled from third trimester TFV gel exposure studies. Methods: Data were restricted to registrants enrolled from studies with planned TFV vaginal gel exposure: MTN-002 (open label, single dose prior to cesarean) and MTN-008 (2:1 placebocontrolled, 7-day use). Registry study visits occurred before delivery when possible, and at < 1, 1, 6 and 12 months for infants. Infant malformation endpoints were determined by geneticists via independent review of physical exam (PE) and photo data. Results: All 16 MTN-002 and 90% (88/98) of MTN-008 mothers were registered, with 25% (n = 4) of MTN-002 and 97% (n = 86) of MTN-008 participants enrolling prior to known pregnancy outcome. Demographics were similar for MTN-008 enrollees and non-enrollees in the registry. Infant retention at 12 months was 88% (MTN-002) and 80% (MTN-008). One defect (ear canal) was noted in MTN-002, a rate (6%) comparable to the 3% US background rate for malformations (p = 0.51); no defects were noted in infants from MTN-008. Compared to placebo (n = 30), TFV gel (n = 58) was not associated with preterm delivery (1/58 (2%) vs. 2/30 (7%), p = 0.27), postpartum hemorrhage (11/58 (19%) vs. 3/30 (10%), p = 0.36), nonreassuring fetal status (3/58 (5%) vs. 1/30 (3%), p = 1.0), chorioamnionitis (1/58 (2%) vs. 2/30 (7%), p = 0.27), gestational diabetes (0/58 (0%) vs. 1/30 (3%), p = 0.34), or abnormal infant PE findings in the first year of life (14/58 (24%) vs. 8 (27%), p = 1.0). Conclusions: This first report from a novel pregnancy registry suggests third trimester TFV gel exposure is not associated with infant malformation or adverse OB or infant outcomes. Future HIV chemoprevention studies should include safety evaluation, including registry participation, for pregnant mothers and their infants.
and government investments in developing country implementation, vertical HIV transmission persists. In Kenya, an estimated 37,000 to 42,000 infants are infected with HIV annually due to mother-to-child transmission (MTCT). This study explored the reasons for MTCT persistence in areas with overall low transmission rates and PMTCT service provision. Methods: A case-control study of HIV-exposed infants (HEI) enrolled in follow-up care between January and June 2012 was conducted at 20 rural health facilities supported by Family AIDS Care and Education Services (FACES) in Nyanza Province, Kenya. Cases were HEI who turned HIV positive, controls were HEI who remained negative at last test; an equal number of controls were randomly selected after matching based on birth month and gender. Data were abstracted from routine PMTCT registers, HEI cards, and infant forms. Logistic regression analysis was conducted to determine factors associated with HIV infection. Results: Forty-five cases and 45 controls were compared. Maternal, clinical and infant factors associated with HIV-infected infants included poor PMTCT service uptake including late enrolment of infant to follow-up, (OR = 0.14, 95%CI: 0.06 0.38), poor infant prophylaxis adherence (OR = 8.32, 95%CI 3.24 - 21.38), and fewer antenatal (ANC) visits (OR = 0.62, 95% CI: 0.41 - 0.96). Mothers of cases were significantly less likely to report having received clinic level HIV education and counseling compared to controls (OR 0.13, 95%CI 0.04 - 0.54 and OR 0.12, 95% CI 0.03 - 0.46). Maternal disclosure, gestation at first ANC visit, and infant feeding type were not significantly associated. Conclusions: Poor PMTCT service uptake and a reported absence of clinic level HIV education and counseling were associated with MTCT. More emphasis on PMTCT service provision including counseling and education are needed to minimize HIV transmission to infants.
PrEP Trials: Preparing for Demos, Participant Experiences P46.01 Preparing for Risk-reduction Counseling on Pre-exposure Prophylaxis for Women in Kenya and South Africa Amy Corneli1, Emily Namey1, Khatija Ahmed2, Kawango Agot3, Jennifer Headley1, Kevin Mckenna1, Joseph Skhosana2, Jacob Odhiambo3
P45.08 A Case Control Study of Factors Associated with HIV Infection Despite Overall Low Transmission Rates in HIV Exposed Infants in Rural Kenya
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Nicollate Awuor Okoko1, Kevin Owuor1, Jayne Lewis Kulzer1,2, George Owino1, Irene Ogolla1, Ronald Wandera3, Elizabeth Anne Bukusi1,2, Craig R. Cohen1,2, Lisa Abuogi1,4 1
Family AIDS Care and Education Services (FACES), Research Care and Training Program (RCTP), Centre for Microbiology Research (CMR), Kenya Medical Research Institute (KEMRI), Kisumu, Kenya, 2University of California San Francisco (UCSF), Departments of Obstetrics, Gynaecology and Reproductive Sciences; Medicine, San Francisco, CA, United States, 3Rongo District Hospital, Ministry of Health, Rongo, Kenya, 4University of Colorado, Department of Paediatrics, Denver, Denver, CO, United States Background: Despite the availability of Prevention of Motherto-Child HIV Transmission (PMTCT) interventions and donor
FHI 360, Durham, NC, United States, 2Setshaba Research Centre, Soshanguve, South Africa, 3Impact Research and Development Organization, Kisumu, Kenya Background: Our previous survey research on pre-exposure prophylaxis (PrEP) and risk compensation with women at HIV risk in Bondo, Kenya, and Soshanguve, South Africa, showed that a considerable minority of women may engage in riskier sexual behavior if taking PrEP. We conducted a small qualitative study to explore perceptions of an informed-choice approach to PrEP counseling. This approach promotes condoms but empowers women who are unable or unwilling to use condoms to make informed decisions regarding their sexual health when taking PrEP. Methods: We conducted eight focus groups with women in Bondo and Soshanguve (four per site). We introduced the counseling approach and presented participants with multiple
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