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Study protocol of "Our Choice": a randomized controlled trial of the integration of safer conception counseling to transform HIV family planning services in Uganda.

ABSTRACT: BACKGROUND:About 40% of HIV-positive women in sub-Saharan Africa become pregnant post-diagnosis. Despite about half of their pregnancies being planned, safer conception methods (SCM) are underutilized among serodiscordant couples, partially due to the fact that safer conception counseling (SCC) has not been integrated into routine HIV family planning (FP) services. METHODS:Our Choice is a comprehensive FP intervention that promotes unbiased childbearing consultations to ensure clients receive SCC or contraception services to achieve their desired reproductive goals. The intervention is theoretically grounded and has demonstrated preliminarily feasibility and acceptance through pilot testing. This three-arm cluster randomized controlled trial compares two implementation strategies for integrating Our Choice into routine FP services vs. usual care. Six sites in Uganda will be randomized to receive either (1) Our Choice intervention with enhanced training and supervision provided by study staff (SCC1), (2) Our Choice intervention implemented by the Ministry of Health's standard approach to disseminating new services (SCC2), or (3) existing FP services (usual care). Our Choice and usual care FP services will be implemented simultaneously over a 30-month period. Sixty clients in serodiscordant relationships who express childbearing desires will be enrolled by a study coordinator at each site (n?=?360) and followed for 12 months or post-pregnancy (once, if applicable). Analysis will compare intervention arms (SCC1 and SCC2) to usual care and then to each other (SCC1 vs. SCC2) on the primary outcome of correct use of either SCM (if trying to conceive) or dual contraception (if pregnancy is not desired). Secondary outcomes (i.e., pregnancy, use of prevention of mother-to-child transmission services, condom use, and partner seroconversion) and cost-effectiveness will also be examined. DISCUSSION:Findings will provide critical information about the success of implementation models of varying intensity for integrating SCC into FP, thereby informing policy and resource allocation within and beyond Uganda. TRIAL REGISTRATION:NCT03167879 ClinicalTrials.gov, Registered 30 May, 2017.

SUBMITTER: Goggin K

PROVIDER: S-EPMC6092849 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Study protocol of "Our Choice": a randomized controlled trial of the integration of safer conception counseling to transform HIV family planning services in Uganda.

Goggin Kathy K Hurley Emily A EA Beyeza-Kashesya Jolly J Gwokyalya Violet V Finocchario-Kessler Sarah S Birungi Josephine J Mindry Deborah D Wanyenze Rhoda K RK Wagner Glenn J GJ

Implementation science : IS 20180814 1

<h4>Background</h4>About 40% of HIV-positive women in sub-Saharan Africa become pregnant post-diagnosis. Despite about half of their pregnancies being planned, safer conception methods (SCM) are underutilized among serodiscordant couples, partially due to the fact that safer conception counseling (SCC) has not been integrated into routine HIV family planning (FP) services.<h4>Methods</h4>Our Choice is a comprehensive FP intervention that promotes unbiased childbearing consultations to ensure cli ...[more]

PMID: 30107843

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Project description:BackgroundDespite significant interest in integrating sexual and reproductive health (SRH) services into HIV services, less attention has been paid to linkages in the other direction. Where women and girls are at risk of HIV, offering HIV testing services (HTS) during their visits to family planning (FP) services offers important opportunities to address both HIV and unwanted pregnancy needs simultaneously.MethodsWe conducted a systematic review of studies comparing FP services with integrated HTS to those without integrated HTS or with a lower level of integration (e.g., referral versus on-site services), on the following outcomes: uptake/counseling/offer of HTS, new cases of HIV identified, linkage to HIV care and treatment, dual method use, client satisfaction and service quality, and provider knowledge and attitudes about integrating HTS. We searched three online databases and included studies published in a peer-reviewed journal prior to the search date of June 20, 2017.ResultsOf 530 citations identified, six studies ultimately met the inclusion criteria. Three studies were conducted in Kenya, and one each in Uganda, Swaziland, and the USA. Most were in FP clinics. Three were from the Integra Initiative. Overall rigor was moderate, with one cluster-randomized trial. HTS uptake was generally higher with integrated sites versus comparison or pre-integration sites, including in adjusted analyses, though outcomes varied slightly across studies. One study found that women at integrated sites were more likely to have high satisfaction with services, but experienced longer waiting times. One study found a small increase in HIV seropositivity among female patients testing after full integration, compared to a dedicated HIV tester. No studies comparatively measured linkage to HIV care and treatment, dual method use, or provider knowledge/attitudes.ConclusionsGlobal progress and success for reaching SRH and HIV targets depends on progress in sub-Saharan Africa, where women bear a high burden of both unintended pregnancy and sexually transmitted infections, including HIV. While the evidence base is limited, it suggests that integration of HTS into FP services is feasible and has potential for positive joint outcomes. The success and scale-up of this approach will depend on population needs and health system factors.

Project description:BackgroundWith the advent of effective treatment, women living with HIV can plan for pregnancy while minimizing risk of transmission to infants and seronegative partners. Family planning (FP) services tend to focus solely on addressing contraceptive need, but HIV-positive women-including female sex workers-often plan to have children someday. Various "safer conception" strategies are now available to support women living with HIV achieve fertility intentions, and integrated HIV/FP services may be a promising platform to offer these services.MethodsAt integrated community-based HIV/FP service delivery sites operated by Jhpiego's Sauti project in Dar es Salaam, we conducted exit interviews with 300 HIV-positive female sex workers. Descriptive analyses were conducted to describe their desire for children, use of condoms and other modern contraceptive methods, self-reported viral suppression, and knowledge of and interest in safer conception strategies. We conducted bivariate and multivariate logistic regression analysis to examine correlates of fertility desire among respondents.ResultsMedian age of participants was 32. Nearly one-third wished to have a child within two years. Seventy-two percent had heard of having the HIV-positive partner taking ART to reduce sexual transmission during pregnancy attempts. Thirty-one percent felt the amount of FP content covered in the consultation was "too little." Factors significantly associated with desire for children were having a nonpaying partner (adjusted odds ratio [AOR] 2.18, 95% confidence interval [CI]1.13-4.20) and having fewer children (AOR 0.65, 95% CI 0.48-0.87). Viral suppression was not associated with fertility desire.ConclusionsSex workers living with HIV attending integrated HIV/FP services have need for both contraception as well as safer conception counseling. This integrated service delivery modality is a promising platform for providing safer conception services. FP counseling for HIV-positive women should be broadened to broach the topic of safer pregnancy, as well as explicit counseling on strategies to minimize risk of sexual transmission to partners.

Project description:BackgroundSafer conception counseling (SCC) to promote the use of safer conception methods (SCM) is not yet part of routine family planning or HIV care. Guidelines for the use of SCM have been published, but to date there are no published controlled evaluations of SCC. Furthermore, it is unknown whether standard methods commonly used in resource constrained settings to integrate new services would be sufficient, or if enhanced training and supervision would result in a more efficacious approach to implementing SCC.MethodsIn a hybrid, cluster randomized controlled trial, six HIV clinics were randomly assigned to implement the SCC intervention Our Choice using either a high (SCC1) or low intensity (SCC2) approach (differentiated by amount of training and supervision), or existing family planning services (usual care). Three hundred eighty-nine HIV clients considering childbearing with an HIV-negative partner enrolled. The primary outcome was self-reported use of appropriate reproductive method (SCM if trying to conceive; modern contraceptives if not) over 12 months or until pregnancy.ResultsThe combined intervention groups used appropriate reproductive methods more than usual care [20.8% vs. 6.9%; adjusted OR (95% CI)=10.63 (2.79, 40.49)], and SCC1 reported a higher rate than SCC2 [27.1% vs. 14.6%; OR (95% CI)=4.50 (1.44, 14.01)]. Among those trying to conceive, the intervention arms reported greater accurate use of SCM compared to usual care [24.1% vs. 0%; OR (95% CI)=91.84 (4.94, 1709.0)], and SCC1 performed better than SCC2 [34.6% vs. 11.5%; OR (95% CI)=6.43 (1.90, 21.73)]. The arms did not vary on modern contraception use among those not trying to conceive. A cost of $631 per person was estimated to obtain accurate use of SCM in SCC1, compared to $1014 in SCC2.ConclusionsMore intensive provider training and more frequent supervision leads to greater adoption of complex SCM behaviors and is more cost-effective than the standard low intensity implementation approach.Trial registrationClinicaltrials.gov, NCT03167879 ; date registered May 23, 2017.

Project description:BackgroundMany people living with HIV would like to have children but family planning (FP) services often focus on only contraception. Availability of safer conception services is still very low in most low income countries. In this study we assessed the knowledge and use of safer conception methods (SCM) among HIV infected women in HIV care in Uganda to inform integration of safer conception in existing FP services.MethodsData were accrued from a nationally representative cross-sectional survey of 5198 HIV+ women aged 15-49?years from 245 HIV clinics in Uganda. Knowledge and use of safer conception methods and associated factors were determined. The measure of association was prevalence ratio (PR) with corresponding 95% confidence intervals, obtained using a modified Poisson regression via generalized linear models. All the analyses were conducted using STATA version 12.0.ResultsOverall knowledge of any safer conception method was 74.1% (3852/5198). However only 13.2% knew 3 to 4 methods, 18.9% knew only 2 methods and 42% knew only one method. Knowledge of specific SCM was highest for timed unprotected intercourse (TUI) at 39% (n?=?2027) followed by manual self-insemination (MSI) at 34.8% (n?=?1809), and pre-exposure prophylaxis (PrEP) at 24.8% (n?=?1289). Knowledge of SCM was higher in the Eastern region (84.8%, P?<?0.001), among women in HIV-discordant relationships (76.7%, p?<?0.017), and those on ART (74.5%, p?<?0.034). Overall, 1796 (34.6%) women were pregnant or reported a birth in the past 2?years-overall use of SCM in this group was 11.6% (209/1796). The odds of use of SCM were significantly lower in Kampala [adj. PR?=?0.489(0.314, 0.764)] or Eastern region [adj.PR?=?0.244; (0.147, 0.405)] compared to Northern region. Higher odds of SCM use were associated with HIV status disclosure to partner [adj.PR?=?2.613(1.308, 5.221)] and sero-discordant compared to HIV+ concordant relationship [adj.PR?=?1.637(1.236, 2.168)]. Pre-existing knowledge of any one SCM did not influence SCM use.ConclusionsKnowledge and use of SCM among HIV+ women in care is low. Efforts to improve HIV status disclosure, integration of safer conception into FP and HIV services and regional efforts to promote sensitization and access to safer conception can help to increase uptake of safer conception methods.

Project description:BackgroundKenya has made remarkable progress in integrating a range of reproductive health services with HIV/AIDS services over the past decade. This study describes a sub-set of outcomes from the Bill & Melinda Gates Foundation (BMGF)-funded Jhpiego-led Kenya Urban Reproductive Health Initiative (Tupange) Project (2010-2015), specifically addressing strengthening family planning (FP) integration with a range of primary care services including HIV testing and counselling, HIV care services, and maternal, newborn and child care.MethodsA cross-sectional study was conducted between August and October 2013 in the cities of Mombasa, Nairobi and Kisumu in Kenya to assess the level of FP integration across six other service delivery areas (antenatal care clinic, maternity wards, postnatal care clinic, child welfare clinic, HIV testing and counseling (HTC) clinics, HIV/AIDS services in comprehensive care clinics). The variables of interest were level of integration, provider knowledge, and provider skills. Routine program monitoring data on workload was utilized for sampling, with additional data collected and analyzed from twenty health facilities selected for this study, along with client exit interviews. Descriptive analysis and Chi-square/ Fishers Exact tests were done to explore relationships between variables of interest.ResultsIntegration of FP occurred in all the five service areas to varying degrees. Service provider FP knowledge in four service delivery areas (HTC clinic, antenatal clinic, postnatal clinic, and child welfare clinic) increased with increasing levels of integration. Forty-seven percent of the clients reported that time spent accessing FP services in the HTC clinic was reasonable. However, no FP knowledge was reported from service providers in HIV/AIDS comprehensive care clinics in all levels of integration despite observed provision of counseling and referral for FP services.ConclusionsIntegration of FP services in other primary care service areas including HTC clinic can be enhanced through targeted interventions at the facility. A holistic approach to address service providers' capacity and attitudes, ensuring FP commodity security, and creating a supportive environment to accommodate service integration is necessary and recommended. Additional studies are necessary to identify ways of enhancing FP integration, particularly with HIV/AIDS care services.

Project description:BackgroundPublic health resources are often deployed in developing countries by foreign governments, national governments, civil society and the private health clinics, but seldom in ways that are coordinated within a particular community or population. The lack of coordination results in inefficiencies and suboptimal results. Organizational network analysis can reveal how organizations interact with each other and provide insights into means of realizing better public health results from the resources already deployed. Our objective in this study was to identify the missed opportunities for the integration of HIV care and family planning services and to inform future network strengthening.MethodsIn two sub-cities of Addis Ababa, we identified each organization providing either HIV care or family planning services. We interviewed representatives of each of them about exchanges of clients with each of the others. With network analysis, we identified network characteristics in each sub-city network, such as referral density and centrality; and gaps in the referral patterns. The results were shared with representatives from the organizations.ResultsThe two networks were of similar size (25 and 26 organizations) and had referral densities of 0.115 and 0.155 out of a possible range from 0 (none) to 1.0 (all possible connections). Two organizations in one sub-city did not refer HIV clients to a family planning organization. One organization in one sub-city and seven in the other offered few HIV services and did not refer clients to any other HIV service provider. Representatives from the networks confirmed the results reflected their experience and expressed an interest in establishing more links between organizations.ConclusionsBecause of organizations not working together, women in the two sub-cities were at risk of not receiving needed family planning or HIV care services. Facilitating referrals among a few organizations that are most often working in isolation could remediate the problem, but the overall referral densities suggests that improved connections throughout might benefit conditions in addition to HIV and family planning that need service integration.

Dataset Information

Study protocol of "Our Choice": a randomized controlled trial of the integration of safer conception counseling to transform HIV family planning services in Uganda.

Publications

Study protocol of "Our Choice": a randomized controlled trial of the integration of safer conception counseling to transform HIV family planning services in Uganda.

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