PI: KAITLIN GECK
Affiliation: VANDERBILT UNIVERSITY SCHOOL OF MEDICINE & INSTITUTE OF GLOBAL HEALTHV
Approving ERC: AMREF
Approval Date: 11/30/2017
Duration: January- March, 2018
Lwala Community Alliance serves to build the capacity of people of North Kamagambo in Migori County, Kenya to advance their own comprehensive well-being. Part of this initiative includes providing contraceptives and education about family planning.
Multipurpose prevention technologies (MPTs) are biomedical interventions that provide protection from both sexually transmitted infections, such as HIV, and unintended pregnancy. A dual-purpose product that combines HIV and pregnancy prevention could offer advantages over single-indication products. In recent population-based surveys, 4 in 10 women in Kenya and 89% of women ages 18–24 in South Africa were current users of modern contraceptive methods. A contraceptive product that also confers protection against HIV could lead to greater coverage of prevention methods in these countries than a single-purpose HIV prevention method.
A multipurpose prevention technology (MPT) that combines HIV and pregnancy prevention is a promising women's health intervention, particularly for young women. However, little is known about the drivers of acceptability and product choice for MPTs in this population. This paper explores approval ratings and stated choice across three different MPT delivery forms among potential end-users.
Sub-Saharan Africa has the highest prevalence and incidence of HIV-1 infection in the world, and the region also has high fertility rates, with approximately 14 million pregnancies annually considered unintended. As an example, in Kenya, HIV-1 seroprevalence is 7.1%, 60% of HIV-1 infected adults are women, the total fertility rate is 4.7 births per woman, and it has been estimated that there is a 25% unmet need for family planning among married women.
Effective contraception reduces unintended pregnancies and is a central strategy to reduce vertical HIV-1 transmission for HIV-1 infected women.
In female-positive HIV-serodiscordant couples desiring children, home timed vaginal insemination of semen during the fertile period along with consistent condom use may reduce the risk of HIV transmission when the man is HIV-uninfected. In sub-Saharan Africa, up to 45% of HIV-infected women desire to have more children. HIV viral load assessment is not routinely available in low-resource countries for monitoring adherence and response to antiretroviral therapy. Therefore, in these settings, timed unprotected intercourse without assurance of HIV viral suppression may pose unnecessary risks. Timed vaginal insemination, a simple and affordable intervention, can be considered an adjunct method and option of safer conception for HIV prevention with treatment of the HIV-infected partner and/or pre-exposure prophylaxis.
More than two-thirds of the 35 million people diagnosed with HIV/AIDS worldwide live in Sub-Saharan Africa. Of these affected individuals, in excess of 1.6 million are living in Kenya. Urban prevalence rates of HIV/AIDS are almost twice as high as those reported in rural areas, and Kenyan urban slum residents have higher rates. Estimates suggest that 72% of all urban residents in Sub-Saharan Africa live in slums. Similarly, up to 70% of individuals living in the Kenyan capital of Nairobi are resident in slums or slum-like areas, making slum populations a substantial but poorly studied group.The aim of the present study was to investigate contraceptive use and its determinants among people with HIV/AIDS living in Nairobi slums.
For HIV serodiscordant couples in resource-limited settings, pregnancy is common despite the risk of sexual and/or perinatal HIV transmission. Some safer conception strategies to reduce HIV transmission during pregnancy attempts are available but often not used for reasons including knowledge, accessibility, preference and others. We sought to understand Kenyan health providers’ and HIV serodiscordant couples’ perspectives and experiences with safer conception.
Natural conception poses substantial risk of HIV transmission in HIV serodiscordant partnerships (Kisakye, Akena & Kaye, 2010; Mathews et al.,2013; Nattabi, Thompson, Orach & Earnest 2012) yet fertility rates in such partnerships are often high (Heffron et al., 2010; Ngure et al., 2012). Fertility desires among HIV-infected men and women are strong and influenced by personal, interpersonal, and cultural factors (Chen, Phillips, Kanouse, Collins & Miu, 2001; Cooper et al., 2009; Kaida et al.,2013; Nattabi, Thompson, Orach & Earnest, 2009; Paiva et al., 2007). Assisted reproductive technologies (Mathews, Baeten, Celum & Bangsberg,2010), antiretroviral therapy (ART) to reduce the infectiousness of HIV-infected persons (Cohen et al.,2011), and pre-exposure prophylaxis (PrEP) for HIV-uninfected persons (Baeten et al., 2012) offer new approaches to reduce the risk of horizontal HIV transmission during conception.
Few studies have explored how HIV serodiscordant couples balance fertility desires against their HIV risk and men are rarely included in these studies. We sought to explore fertility intentions, risk considerations, and the acceptability of potential risk reduction strategies among both members of Kenyan HIV serodiscordant couples who recently conceived, to inform interventions to reduce HIV transmission risk during peri-conception in serodiscordant relationships.
Safer conception strategies (SCS) have the potential to decrease HIV transmission among HIV-discordant couples who desire children. Community perceptions of SCS may influence the scale-up and uptake of these services, but little is known about how communities will react to these strategies. Without community support for SCS, their success as an HIV prevention tool may be limited. The objective of this study is to characterize community perceptions of SCS for HIV-discordant couples in Kisumu, Kenya, to inform ongoing and future safer conception intervention studies in low-resource settings.
In African culture, reproduction is linked to individual identity, worth, and social status (Ujiji et al., 2010; Cooper et al., 2007). Successful antiretroviral therapy (ART) has prompted HIV-infected individuals to pursue fulfillment of childbearing desires. Heterosexual HIV-sero discordant couples may account for at least 50% of new HIV infections in Kenya, and transmission nearly doubles in partnerships where pregnancy occurs (Guthrie et al., 2007; Dunkle et al., 2008; Matthews et al., 2010; Coburn et al., 2011; Brubaker et al., 2011). HIV-serodiscordant couples desiring children knowingly risk HIV transmission with unprotected intercourse. Risk reduction strategies to decrease or eliminate unprotected intercourse for conception should represent a critical target for HIV prevention initiatives.
Timed vaginal insemination (TVI) during the fertile period is a simple, low-cost intervention requiring a syringe and a water-based lubricated condom. However, socio-cultural perceptions concerning the use of assisted reproductive methods for achieving pregnancy outside of unprotected penile-vaginal penetration may not be acceptable from a cultural or a personal perspective (Horbst, 2012). Prior to initiating an observational study evaluating acceptability and feasibility of TVI (ClinicalTrials.gov identifier: NCT01468753), we conducted formative research in Kisumu, Kenya to assess how HIV-serodiscordant couples and healthcare providers would approach TVI.
Future HIV prevention options for women will likely include Antiretroviral (ARV)-based intravaginal rings. Valuable insights may be gained by examining user experiences with a similar licensed technology, a contraceptive ring, especially in settings where this technology may not be currently available.
Public health interventions designed to reduce HIV and STI incidence in female sex workers (FSWs) often overlook their broader reproductive health needs. Unintended pregnancy is a major occupational risk factor for FSWs. The objective of this study was to examine the prevalence and correlates of unmet contraceptive need in this key population
Concerns have been raised about efavirenz reducing the effectiveness of contraceptive implants. We aimed to establish whether pregnancy rates differ between HIV-positive women who use various contraceptive methods and either efavirenz-based or nevirapine-based antiretroviral therapy (ART) regimens.
World Health Organization (WHO) guidelines recommend dual contraceptive method use with condoms and another contraceptive to reduce both incidence of HIV/sexually transmitted infection transmission and unintended pregnancies. This qualitative study assessed the barriers to and motivations for dual contraceptive use in Kenyan HIV-serodiscordant couples.
The study will have three parts. During the first part (3 months), baseline data on contraceptive prevalence and unintended pregnancy will be collected at 18 PSCs that are supported by the FACES program in Suba, Kisumu East, Nyatike, Rongo and Migori Districts. Also during this first part, information about knowledge, attitudes and practices related to family planning will be obtained from patients and from clinicians at the sites. During the second part (3 months), an intervention consisting of integrating family planning services will be designed and implemented at twelve of the 18 FACES-supported PSCs. We aim to utilize a 2:1 integration:control model, with delayed integration so as to gradually expand the integration of FP and HIV services throughout the 18 sites, while maintaining the ability to test hypotheses on the effects of integration on health outcomes. After collecting the baseline data, we plan to stratify the clinics into two categories based on the overall patient volume and differences in the structure of family planning provision, i.e., whether or not there is a specific MCH division providing family planning at the site or not. Randomization of sites will then occur among clinics in each of these strata, with a ratio of two intervention sites (integrated model) to one control site (family planning provided in the standard manner at the site). During the third and last part (12 months), data on prevalence more effective contraception and unintended pregnancy will be collected from each of the 18 sites. At the end of part three, information about knowledge, attitudes and practices related to family planning again will be obtained from patients and from clinicians at the sites. In addition, we will administer questionnaires assessing the acceptability of family planning services to patients, and in addition clinic staff will be answer a questionnaire assessing the feasibility of providing integrated family planning services. After 12 months of data collection, the 6 control sites were integrated and data were collected for an additional 11 months from all 18 sites to assess the sustainability of the intervention under the Ministry of Health. The study population will primarily consist of HIV-positive men and non-pregnant, HIV-positive women of reproductive age who obtain care at the FACES-supported PSCs in Suba, Kisumu East, Rongo and Migori Districts in Nyanza Province, Kenya. In addition, study subjects will also include clinic staff at the FACES centers included in the study.
Studies of the effect of hormonal contraceptive use on the risk of HIV-1 acquisition have generated conflicting results. A recent study from Uganda and Zimbabwe found that women using hormonal contraception were at increased risk for HIV-1 if they were seronegative for herpes simplex virus type 2 (HSV-2), but not if they were HSV-2 sero-positive.
A total of 786 patients failing antiretroviral therapy were examined for the presence of HIV genotypes causing broad cross-resistance to nucleos(t)ide analogues. They were found to be present in 40% of patients. The Q151M complex and 67/69 inserts were also recognized in 3% of patients. Although thymidine-associated mutations, which favour drug removal (pyrophosphorolysis), were involved in the majority of cases, mutations reducing drug binding were relatively infrequent, probably because of their effect on
Factors that influence shedding of HIV-1 infected cells in cervical and vaginal secretions may be important determinants of sexual and vertical transmission of the virus. We investigated whether hormonal contraceptive use, vitamin A deficiency, and other variables were risk factors for cervical and vaginal shedding of HIV-infected cells.
This is a double-blind, randomized; placebo-controlled Phase I/II study to assess the safety of a silicone elastomer vaginal ring containing 25mg dapivirine
The goal of this study is to develop and evaluate a theory-based intervention that could be incorporated into routine health services to improve the sexual and reproductive health of women who engage in sex work if demonstrated to be effective. To accomplish this goal, the study will be conducted in two phases. During the first phase of the study, FSWs and service providers in the study sites will assist in the design of the intervention, in an effort to increase the likelihood that it will be accepted, feasible, and effective. Brief formative research will be conducted with FSWs and service providers, followed by working group meetings with self-selected FSWs, service providers, and GSKenya representatives who will review data and work with study investigators and/or their designees to design the intervention. During the second phase of this study, the intervention will be implemented and evaluated.
The study is planned for two sites within Rift Valley Province, Kenya. The first "site" is comprised of two adjacent towns, Naivasha and Gilgil. The town of Nanyuki will serve as the second site.
Based on findings from the formative phase of this study, and on observations and feedback from providers, a package of enhancements to the current package of services delivered to FSW will be implemented and evaluated.
• Family Planning (FP) Messaging for peer educators and informational materials material - Peer educators will be trained using existing materials to deliver accurate messaging on FP/dual method use, during individual encounters and in group sessions.
• Screening for unmet FP need in drop-in centers - Integration of FP needs screening in the service delivery points will increase the number of FSW accessing FP. This will be done through sensitization of service providers and provision of a brief job aid that can be used to screening clients for unmet need, including unmet need for dual method use.
• Providers FP counseling job aid - The AIDS, Population and Health Integrated Assistance (APHIA) Plus project will adapt the existing Balanced Counseling Strategy Plus: A Toolkit for Family Planning Service Providers Working in High HIV/Sexually Transmitted Infection (STI) Prevalence Settings for providers to use within the context of the DICs and in referral sites in the catchment area.
• Commodities - increasing method mix - The methods that will be available to all women attending services at the DIC will be expanded. In addition to the current oral contraceptive pills, DMPA, male and female condoms, both the intra-uterine contraceptive devices (IUCD) and implants will be added to the mix of methods available.
Hours of DIC operation - Based on findings from the formative phase of the study, the hours of operation for DICs will be extended into the late evening hours to accommodate the schedules of FSW.