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Trials
Published in: Trials 1/2011

Open Access 01-12-2011 | Study protocol

Project Masihambisane: a cluster randomised controlled trial with peer mentors to improve outcomes for pregnant mothers living with HIV

Authors: Mary-Jane Rotheram-Borus, Linda Richter, Heidi Van Rooyen, Alastair van Heerden, Mark Tomlinson, Alan Stein, Tamsen Rochat, Julia de Kadt, Nonhle Mtungwa, Lungile Mkhize, Lindo Ndlovu, Lungile Ntombela, W Scott Comulada, Katherine A Desmond, Erin Greco

Published in: Trials | Issue 1/2011

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Abstract

Background

Pregnant women living with HIV (WLH) face daily challenges maintaining their own and their babies' health and mental health. Standard Prevention of Maternal to Child Transmission (PMTCT) programs are not designed to address these challenges.

Methods/Design

As part of a cluster randomized controlled trial, WLH are invited to attend four antenatal and four postnatal small group sessions led by a peer WLH (a Peer Mentor). The WLH and their babies are assessed during pregnancy and at one week, six months, and twelve months post-birth. Mobile phones are used to collect routine information, complete questionnaires and remain in contact with participants over time. Pregnant WLH (N = 1200) are randomly assigned by clinic (N = 8 clinics) to an intervention program, called Masihambisane (n = 4 clinics, n = 600 WLH) or a standard care PMTCT control condition (n = 4 clinics; n = 600 WLH).

Discussion

Data collection with cellular phones are innovative and effective in low-resource settings. Standard PMTCT programs are not designed to address the daily challenges faced by WLH; Peer Mentors may be useful in supporting WLH to cope with these challenges.

Trial registration

ClinicalTrials.gov registration # NCT00972699
Appendix
Available only for authorised users
Literature
1.
2.
3.
Shisana O, Rehle T, Simbayi L, Zuma K, Jooste S, Pillay-van-Wyk V, Mbelle N, Van Zyl J, Parker W, Zungu N: South African national HIV prevalence, incidence, behaviour and communication survey 2008: A turning tide among teenagers?. 2009, Cape Town, South Africa
4.
5.
Maheswaran H, Bland RM: Preventing mother-to-child transmission of HIV in resource-limited settings. Fut Vir. 2009, 4: 165-175. 10.2217/17460794.4.2.165.CrossRef
6.
Verplanken B, Wood W: Interventions to break and create consumer habits. J of PP and Market. 2006, 25: 90-103.
7.
Bwirire L, Fitzgerald M, Zachariah H, Chikafa V, Massaquoi M, Moens M, Kamoto K, Schouten E: Reasons for loss to follow-up among mothers registered in a prevention-of-mother-to-child transmission program in rural Malawi. The Trans of the RSTMH. 2008, 102: 1195-1200.
8.
Varga C, Brookes H: Preventing Mother-to-Child HIV Transmission Among South African Adolescents. J of Ad Research. 2008, 23: 172-205. 10.1177/0743558407310771.CrossRef
9.
Futterman D, Shea J, Besser M, Stafford S, Desmond K, Comulada WS, Greco E: Mamekhaya: A pilot study combining a cognitive-behavioral intervention and mentor mothers with PMTCT services in South Africa. AIDS Care. 2010, 22 (9): 1093-1100. 10.1080/09540121003600352.CrossRefPubMedPubMedCentral
10.
Kownacki RJ, Shadish WR: Does Alcoholics Anonymous Work? Results from a Meta-Analysis of Controlled Experiments. Subst Use & Mis. 2009, 24 (13): 1897-1916.
11.
Silverman PR: Widowhood and Preventive Intervention. Aging and Fam. 1972, 21 (1): 95-102.
12.
NIMH Collaborative HIV/STD Prevention Trial Group: Results of the NIMH Collaborative HIV/Sexually Transmitted Disease Prevention Trial of a Community Popular Opinion Leader Intervention. JAIDS. 2010, 54 (2): 204-214.
13.
Sherman G, Jones S, Coovadia A, Urban M, Bolton K: PMTCT from research to reality -- results from a routine service. SAMJ. 2004, 94: 289-292.PubMed
14.
15.
16.
17.
Finlayson H, Eley B: Treatment and outcome of hospitalised, very young, HIV-infected children. SA J of Child Health. 2007, 1: 140-144.
18.
Stein A, Krebs G, Richter L, Tomkins A, Rochat TJ, Bennish ML: Babies of a pandemic. Arch of Dis in Child. 2005, 90: 116-118. 10.1136/adc.2004.049361.CrossRef
19.
Firn S, Norman IJ: Psychological and emotional impact of an HIV diagnosis. Nursing Times. 1995, 91: 37-39.
20.
Rochat TJ, Richter LM, Doll HA, Buthelezi NP, Tomkins A, Stein A: Depression among pregnant rural South African women undergoing HIV testing. JAMA. 2006, 295: 1376-1378. 10.1001/jama.295.12.1376.CrossRefPubMed
21.
Cook JA, Grey D, Burke-Miller J, Cohen MH, Anastos K, Gandhi M, Richardson J, Wilson T, Young M: Effects of treated and untreated depressive symptoms on highly active antiretroviral therapy use in a US multi-site cohort of HIV-positive women. AIDS Care. 2006, 18: 93-100. 10.1080/09540120500159284.CrossRefPubMed
22.
Starace F, Ammassari A, Trotta MP, Murri R, De Longis P, Izzo C, Scalzini A, D'Arminio Monforte A, Wu AW, Antinori A: Depression is a risk factor for suboptimal adherence to Highly Active Antiretroviral Therapy. JAIDS. 2002, 31: S136-S139.PubMed
23.
24.
Viljoen D, Gossage J, Brooke L, Adnams C, Jones K, Robinson K, Hoyme H, Snell C, Khaole N, Kodituwakku P: Fetal Alcohol Syndrome epidemiology in a South African community: a second study of a very high prevalence area. Journal of St Alc. 2005, 66: 593-604.
25.
May P, Gossage P, Marais AS, Adnams C, Hoyme E: The epidemiology of fetal alcohol syndrome and partial FAS in a South African community. D and Alc Depend. 2007, 88: 259-271. 10.1016/j.drugalcdep.2006.11.007.CrossRef
26.
Zere E, McIntyre D: Inequities in under five child malnutrition in South Africa. International Journal for Equity in Health. 2004, 2: 1-10.
27.
Kelly RH, Russo J, Holt VL, Danielsen BH, Zatzick DF, Walker E, Katon W: Psychiatric and substance use disorders as risk factors for low birth weight and preterm delivery. Obst & Gync. 2002, 100: 1-14.
28.
Cooper PJ, Tomlinson M, Swartz L, Woolgar M, Murray L, Molteno C: Post-partum depression and the mother-infant relationship in a South African peri-urban settlement. Brit J Psych. 1999, 175: 554-558. 10.1192/bjp.175.6.554.CrossRef
29.
Sood B, Delaney-Black V, Covington C, Nordstrom-Klee B, Ager J, Templin T, Janisse J, Martier S, Sokol RJ: Prenatal alcohol exposure and childhood behavior at age 6 to 7 years: I. dose-response effect. Peds. 2001, 108: e34-10.1542/peds.108.2.e34.CrossRef
30.
Myer L, Harrison A: Why do women seek antenatal care late? Perspectives from rural South Africa. J of Midwif & WH. 2003, 48: 268-272.
31.
Berggren G, Alvarez M, Genece E, Amadee-Gedeon PM, Henry M: The Nutrition Demonstration Foyer: A Model for Combating Malnutrition in Haiti. Hoviprep Monograph Series No 2, International Food and Nutrition Program of MIT. 1984, Cambridge, MA: MIT Press
32.
Teasdale C, Besser M: Enhancing PMTCT programmes through psychosocial support and empowerment of women: the mothers2mothers model of care. The SA J of HIV. 2008, Summer: 60-64.
33.
34.
35.
36.
37.
Leshabari S, Koniz-Booher P, Astrom A, de Paoli M, Moland K: Translating global recommendations on HIV and infant feeding to the local context: the development of culturally sensitive counselling tools in the Kilimanjaro Region, Tanzania. Implement Sci. 2006, 1: 22-10.1186/1748-5908-1-22.CrossRefPubMedPubMedCentral
38.
Cox J, Holden J, Sagovsky R: Detection of postnatal depression: development of the 10-item Edinburgh postnatal depression scale. Brit J of Psych. 1987, 150: 782-786. 10.1192/bjp.150.6.782.CrossRef
39.
Abidin R: Parenting Stress Index, Professional Manual. 1995, Odessa, Florida: Psychological Assessment Resources, Inc, Third
40.
Barrera M, Sandler I, Ramsay T: Preliminary development of a scale of social support: studies on college students. Amer J of Comm Psych. 2005, 9: 435-447. 10.1007/BF00918174.CrossRef
41.
Weiss R: Modeling Longitudinal Data. 2005, New York: Springer-Verlag
42.
Breslow NE, Clayton DG: Approximate Inference in Generalized Linear Mixed Models. J of ASA. 2003, 88: 9-25.
43.
Hedeker D, Mermelstein R: Analysis of longitudinal substance use outcomes using ordinal random-effects regression models. Addict. 2000, 95: 381-394.CrossRef
44.
Schafer JL: Multiple imputation: a primer. Statistical Methods in Medical Research. 1999, 8: 3-15. 10.1191/096228099671525676.CrossRefPubMed
45.
Schafer JL: Analysis of incomplete multivariate data. 1997, New York: Chapman & HallCrossRef
46.
Amoateng A, Richter L: The state of families in South Africa. The State of the Nation: South Africa 2003-2004. Edited by: Habib D, Southall R. 2003, Pretoria, South Africa: Human Sciences Research Council Press, 242-267.
Metadata
Title
Project Masihambisane: a cluster randomised controlled trial with peer mentors to improve outcomes for pregnant mothers living with HIV
Authors
Mary-Jane Rotheram-Borus
Linda Richter
Heidi Van Rooyen
Alastair van Heerden
Mark Tomlinson
Alan Stein
Tamsen Rochat
Julia de Kadt
Nonhle Mtungwa
Lungile Mkhize
Lindo Ndlovu
Lungile Ntombela
W Scott Comulada
Katherine A Desmond
Erin Greco
Publication date
01-12-2011
Publisher
BioMed Central
Published in
Trials / Issue 1/2011
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-12-2

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