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Implementation Science
Published in: Implementation Science 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: Kathy Goggin, Emily A. Hurley, Jolly Beyeza-Kashesya, Violet Gwokyalya, Sarah Finocchario-Kessler, Josephine Birungi, Deborah Mindry, Rhoda K. Wanyenze, Glenn J. Wagner

Published in: Implementation Science | Issue 1/2018

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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.
Literature
1.
Wanyenze RK, Tumwesigye NM, Kindyomunda R, Beyeza-Kashesya J, Atuyambe L, Kansiime A, et al. Uptake of family planning methods and unplanned pregnancies among HIV-infected individuals: a cross-sectional survey among clients at HIV clinics in Uganda. J Int AIDS Soc. 2011;14:35.CrossRefPubMedPubMedCentral
2.
Beyeza-Kashesya J, Kaharuza F, Mirembe F, Neema S, Ekstrom AM, Kulane A. The dilemma of safe sex and having children: challenges facing HIV sero-discordant couples in Uganda. Afr Health Sci. 2009;9:2–12.PubMedPubMedCentral
3.
Wagner G, Linnemayr S, Kityo C, Mugyenyi P. Factors associated with intention to conceive and its communication to providers among HIV clients in Uganda. Matern Child Health J. 2012;16:510–8.CrossRefPubMed
4.
Heys J, Kipp W, Jhangri GS, Alibhai A, Rubaale T. Fertility desires and infection with the HIV: results from a survey in rural Uganda. AIDS. 2009;23(Suppl 1):S37–45.CrossRefPubMed
5.
Kakaire O, Osinde M, Kaye D. Factors that predict fertility desires for people living with HIV infection at a support and treatment centre in Kabale. Uganda Reprod Health. 2010;7:27.CrossRefPubMed
6.
7.
8.
9.
Agadjanian V, Hayford SR. PMTCT, HAART, and childbearing in Mozambique: an institutional perspective. AIDS Behav. 2009;13(SUPPL. 1):103–12.CrossRefPubMed
10.
11.
12.
Moodley J, Cooper D, Mantell JE, Stern E. Health care provider perspectives on pregnancy and parenting in HIV-positive individuals in South Africa. BMC Health Serv Res. 2014;14:384.CrossRefPubMedPubMedCentral
13.
Nduna M, Farlane L. Women living with HIV in South Africa and their concerns about fertility. AIDS Behav. 2009;13(SUPPL. 1):62–5.CrossRefPubMed
14.
Myer L, Morroni C, Cooper D. Community attitudes towards sexual activity and childbearing by HIV-positive people in South Africa. AIDS Care. 2006;18:772–6.CrossRefPubMed
15.
16.
Matthews LT, Bajunirwe F, Kastner J, Sanyu N, Akatukwasa C, Ng C, et al. “I always worry about what might happen ahead”: implementing safer conception services in the current environment of reproductive counseling for HIV-affected men and women in Uganda. Biomed Res Int. 2016;2016:4195762.CrossRefPubMedPubMedCentral
17.
Finocchario-Kessler S, Wanyenze RK, Mindry D, Beyeza-Kashesya J, Goggin K, Nabiryo C, et al. “‘I may not say we really have a method, it is gambling work’”: knowledge and acceptability of safer conception methods among providers and HIV clients in Uganda. Health Care Women Int. 2014;35:896–917.CrossRefPubMedPubMedCentral
18.
Barreiro P, del Romero J, Leal M, Hernando V, Asencio R, de Mendoza C, et al. Natural pregnancies in HIV-serodiscordant couples receiving successful antiretroviral therapy. J Acquir Immune Defic Syndr. 2006;43:324–6.CrossRefPubMed
19.
Matthews LT, Mukherjee JS. Strategies for harm reduction among HIV-affected couples who want to conceive. AIDS and Behavior. 2009;13(SUPPL. 1):5–11.CrossRefPubMed
20.
Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the. https://​aidsinfo.​nih.​gov/​guidelines. Accessed 19 Jun 2018.
21.
Taylor GP, Clayden P, Dhar J, Gandhi K, Gilleece Y, Harding K, et al. British HIV Association guidelines for the management of HIV infection in pregnant women 2012. HIV Med. 2012;13(Suppl 2):87–157.CrossRefPubMed
22.
Loutfy MR, Margolese S, Money DM, Gysler M, Hamilton S, Yudin MH. Canadian HIV pregnancy planning guidelines: no. 278, June 2012. Int J Gynecol Obstet. 2012;119:89–99.CrossRef
23.
Bekker L-G, Black V, Myer L, Rees H, Cooper D, Mall S, et al. Guideline on safer conception in fertile HIV-infected individuals and couples. South African J HIV Med. 2011;12:31–44.CrossRef
24.
World Health Organization. Consolidated guideline on sexual and reproductive health and rights of women living with HIV. Geneva: World Health Organization; 2017.
25.
Matthews LT, Crankshaw T, Giddy J, Kaida A, Smit JA, Ware NC, et al. Reproductive decision-making and periconception practices among HIV-positive men and women attending HIV services in Durban. South Africa AIDS Behav. 2013;17:461–70.CrossRefPubMed
26.
Steiner RJ, Black V, Rees H, Schwartz SR. Low receipt and uptake of safer conception messages in routine HIV care: findings from a prospective cohort of women living with HIV in South Africa. JAIDS J Acquir Immune Defic Syndr. 2016;72:105–13. CrossRefPubMed
27.
Wagner GJ, Linnemayr S, Goggin K, Mindry D, Beyeza-Kashesya J, Finocchario-Kessler S, et al. Prevalence and correlates of use of safer conception methods in a prospective cohort of Ugandan HIV-affected couples with fertility intentions. AIDS Behav. 2017;21(4):1–9.
28.
Wagner GJ, Goggin K, Mindry D, Beyeza-Kashesya J, Finocchario-Kessler S, Woldetsadik MA, et al. Correlates of use of timed unprotected intercourse to reduce horizontal transmission among Ugandan HIV clients with fertility intentions. AIDS Behav. 2015;19:1078–88.CrossRefPubMedPubMedCentral
29.
30.
Breitnauer BT, Mmeje O, Njoroge B, Darbes LA, Leddy A, Brown J. Community perceptions of childbearing and use of safer conception strategies among HIV-discordant couples in Kisumu. Kenya J Int AIDS Soc. 2015;18:19972.CrossRefPubMed
31.
Ugandan Ministry of Health, ORC Macro. Uganda HIV/AIDS sero-behavioral survey 2004–2005. Calverton: Uganda Ministry of Health and ORC Macro; 2006.
32.
Muyindike W, Fatch R, Steinfield R, Matthews LT, Musinguzi N, Emenyonu NI, et al. Contraceptive use and associated factors among women enrolling into HIV care in southwestern Uganda. Infect Dis Obstet Gynecol. 2012;2012:340782.CrossRefPubMedPubMedCentral
33.
UNAIDS. Uganda country report. Kampala: Uganda Ministry of Health; 2014.
34.
35.
Finocchario-Kessler S, Clark KF, Khamadi S, Gautney BJ, Okoth V, Goggin K, et al. Progress toward eliminating mother to child transmission of HIV in Kenya: review of treatment guideline uptake and pediatric transmission at four government hospitals between 2010 and 2012. AIDS Behav. 2016;20:2602–11.CrossRefPubMed
36.
Sibanda EL, Weller IVD, Hakim JG, Cowan FM. The magnitude of loss to follow-up of HIV-exposed infants along the prevention of mother-to-child HIV transmission continuum of care: a systematic review and meta-analysis. AIDS. 2013;27:2787–97.CrossRefPubMedPubMedCentral
37.
Mindry D, Woldetsadik MA, Wanyenze RK, Finocchario-Kessler S, Goggin K, Wagner GJ. Benefits and challenges of safer conception counseling for PLHIV in Uganda. Int Perspect Sex Reprod Health. 2018;44(1):xx–xx. https://​doi.​org/​10.​1363/​44e5718.
38.
Mindry D, Wanyenze RK, Beyeza-Kashesya J, Woldetsadik MA, Finocchario-Kessler S, Goggin K, et al. Safer conception for couples affected by HIV: structural and cultural considerations in the delivery of safer conception care in Uganda. AIDS Behav. 2017;21:2488–96.CrossRefPubMed
39.
40.
41.
Woldetsadik MA, Goggin K, Staggs VS, Wanyenze RK, Beyeza-Kashesya J, Mindry D, et al. Safer conception methods and counseling: psychometric evaluation of new measures of attitudes and beliefs among HIV clients and providers. AIDS Behav. 2016;20:1370–81.CrossRefPubMedPubMedCentral
42.
Taljaard M, Donner A, Villar J, Wojdyla D, Velazco A, Bataglia V, et al. Intracluster correlation coefficients from the 2005 WHO Global Survey on Maternal and Perinatal Health: implications for implementation research. Paediatr Perinat Epidemiol. 2008;22:117–25.CrossRefPubMed
43.
Klar N, Donner A, Gyorkos T. Cluster randomization trials in tropical medicine: a case study. Trans R Soc Trop Med Hyg. 1995;89:454–9.CrossRefPubMed
44.
45.
46.
Preacher KJ, Zyphur MJ, Zhang Z. A general multilevel SEM framework for assessing multilevel mediation. Psychol Methods. 2010;15:209–33.CrossRefPubMed
47.
48.
Schwartz SR, Mehta SH, Taha TE, Rees HV, Venter F, Black V. High pregnancy intentions and missed opportunities for patient-provider communication about fertility in a South African cohort of HIV-positive women on antiretroviral therapy. AIDS Behav. 2012;16:69–78.CrossRefPubMed
49.
Scientific software development GmbH. Atlas.ti (Version 8). Berlin; 2017.
50.
Bernard HR, Ryan GW. Analyzing qualitative data: systematic approaches. Anal. 2010;8:451.
51.
Lincoln YS, Guba EG. Naturalistic inquiry. 1985.
52.
MacQueen KM, McLellan E, Kay K, Milstein B. Codebook development for team-based qualitative analysis. Field Methods. 1998;10:31–6.
53.
54.
Metadata
Title
Study protocol of “Our Choice”: a randomized controlled trial of the integration of safer conception counseling to transform HIV family planning services in Uganda
Authors
Kathy Goggin
Emily A. Hurley
Jolly Beyeza-Kashesya
Violet Gwokyalya
Sarah Finocchario-Kessler
Josephine Birungi
Deborah Mindry
Rhoda K. Wanyenze
Glenn J. Wagner
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Implementation Science / Issue 1/2018
Electronic ISSN: 1748-5908
DOI
https://doi.org/10.1186/s13012-018-0793-y

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