TY - JOUR
T1 - Primary HIV prevention in pregnant and lactating Ugandan women
T2 - A randomized trial
AU - the PRIMAL Study Team
AU - Homsy, Jaco
AU - King, Rachel
AU - Bannink, Femke
AU - Namukwaya, Zikulah
AU - Vittinghof, Eric
AU - Amone, Alexander
AU - Ojok, Francis
AU - Rukundo, Gordon
AU - Amama, Sharon
AU - Etima, Juliane
AU - Matovu, Joyce
AU - Weissglas, Fitti
AU - Ojom, Lawrence
AU - Atim, Pamela
AU - Darbes, Lynae
AU - Byamugisha, Josaphat
AU - Rutherford, George
AU - Katabira, Elly
AU - Fowler, Mary Glenn
N1 - Funding Information:
This study was funded by grant R01HD070767 of the National Institutes of Health/ National Institute for Child Health and Human Development awarded to JH at the University of California San Francisco. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. We would like to thank the women, men and children who participated in the PRIMAL study, the Makerere University John Hopkins University Research Collaboration, AVSI Foundation, and all the administrative staff at St Joseph Hospital in Kitgum and Mulago Hospital in Kampala, who made the study possible. We are particularly grateful to Uganda’s Ministry of Health for its continuous support during the planning and implementation of this study. We also wish to acknowledge the invaluable contribution and dedication of the PRIMAL Study Team listed hereafter in alphabetical order by affiliation—Kenneth Mwambi (mwam-bik@gmail.com) is the lead author for this group: Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda: Regina Adoo, Sandra Agondeze, Joshua Buule, Alice Elwana, Elizabeth Kakande, Ruth Kayondo, Grace Kezaabu, Max Kiwewa, Beatrice Kibuuka, Sarah Lunkuse, Kenneth Mwambi, Josephine Nabukenya, Sarah Nakabuye, Noor Nakigozi, Gorrethy Nalubega, Esther Nambi, Halima Namukasa, Christine Namulwasike, Brenda Namusoke, Maria Nansasi, Irene Viola Nantongo, Vivian Ntono, Joyce Rwechungura, Gertrude Sentongo, Jane Ssebaggala, Ruth Ssentongo, and Anitah Wanyana. AVSI Foundation, Kampala and Kitgum, Uganda: Michael Adengo, Phiona Agwalo, Mirriam Ajok, Concy Akot, Chiara Akumu, Josephine Aparo, Justine Lagol, Emily Likico Opu, Florence Ochan, Juliet Ogwang, Michael Okwera, David Oryema, Erick Otema, and Betty Oweka.
PY - 2019/2
Y1 - 2019/2
N2 - Background The ‘Primary HIV Prevention among Pregnant and Lactating Ugandan Women’ (PRIMAL) study aimed to assess the effectiveness of an enhanced HIV counseling intervention for preventing HIV acquisition among HIV-uninfected mothers during pregnancy and throughout the breastfeeding period. Methods We conducted an unblinded randomized control trial between 22 February 2013 and 22 April 2016 to assess the effectiveness of an extended repeat HIV testing and enhanced counseling (ERHTEC) intervention aimed at preventing primary HIV infection among HIV-uninfected pregnant and lactating women in Uganda. HIV-uninfected pregnant women aged 15–49 were enrolled 1:1 individually or in couples together with their partner. Enrolled women and couples were randomized 1:1 to an intervention (ERHTEC) or control (extended repeat HIV testing and standard counseling) group and followed up to 24 months postpartum or six weeks past complete cessation of breastfeeding, whichever came first. Both groups were tested for sexually transmitted infections (STIs) and HIV at enrollment, delivery, 3 and 6 months postpartum and every 6 months thereafter until the end of follow-up. The intervention group received enhanced HIV prevention counseling every 3 months throughout follow-up. The control group received standard counseling at the time of HIV retesting. Both intervention and control couples were offered couple HIV testing and counseling at all study visits. Main outcome measures Frequency of condom use and incidence of HIV, syphilis, gonorrhea, chlamydia and trichomoniasis over follow-up. Results Between February 2013 and April 2014, we enrolled 820 HIV-uninfected pregnant women presenting for antenatal care individually (n = 410) or in couples (n = 410 women and 410 partners) in one urban and one rural public Ugandan hospital. Women’s median age was 24 years (IQR 20–28 years). At baseline, participants did not differ in any socio-demographic, reproductive health, HIV testing history, sexual behavior, medical history or STI status characteristics; 96% (386/402) of couples were tested and counseled for HIV together with their partners at enrolment, 2.1% (7/329) of whom were found to be HIV-infected. Six hundred twenty-five (76%) women completed follow-up as per protocol (S1 Protocol). Women were followed for an average of 1.76 years and cumulated 1,439 women-years of follow-up or 81% of the maximum 1,779 women-years of follow-up assuming no dropouts. Men were followed for an average of 1.72 years. The frequency of consistent condom use and the proportion of women who used condoms over the last 3 months or at last vaginal sex increased substantially over follow-up in both arms, but there were no statistically significant differences in increases between the intervention and control arms. During follow-up, on average 42% (range 36%-46%) of couple partners were counseled together. Between 3.8% and 7.6% of women tested positive at any follow-up visit for any STI including syphilis, gonorrhea, C. trachomatis or T. vaginalis. Four women (two in each arm) and no enrolled men became infected with HIV, representing an overall HIV incidence rate of 0.186 per 100 person-years. Three of the women seroconverters had enrolled individually, one as a couple. At or before seroconversion, all four women reported their partners had extramarital relationships and/or had not disclosed their suspected HIV-infected status. There were no statistically significant differences between study arms for STI or HIV incidences. Conclusions A sustained enhanced HIV prevention counseling intervention for up to 2 years postpartum among pregnant and breastfeeding women did not have a statistically significant effect on condom use or HIV incidence among these women. However, in both study arms, condom use increased over follow-up while STI and HIV incidence remained very low when compared to similar cohorts in and outside Uganda, suggesting that repeat HIV testing during breastfeeding, whether with enhanced or standard counseling, may have had an unintended HIV preventive effect among pregnant and lactating women in this setting. Further research is needed to verify this hypothesis.
AB - Background The ‘Primary HIV Prevention among Pregnant and Lactating Ugandan Women’ (PRIMAL) study aimed to assess the effectiveness of an enhanced HIV counseling intervention for preventing HIV acquisition among HIV-uninfected mothers during pregnancy and throughout the breastfeeding period. Methods We conducted an unblinded randomized control trial between 22 February 2013 and 22 April 2016 to assess the effectiveness of an extended repeat HIV testing and enhanced counseling (ERHTEC) intervention aimed at preventing primary HIV infection among HIV-uninfected pregnant and lactating women in Uganda. HIV-uninfected pregnant women aged 15–49 were enrolled 1:1 individually or in couples together with their partner. Enrolled women and couples were randomized 1:1 to an intervention (ERHTEC) or control (extended repeat HIV testing and standard counseling) group and followed up to 24 months postpartum or six weeks past complete cessation of breastfeeding, whichever came first. Both groups were tested for sexually transmitted infections (STIs) and HIV at enrollment, delivery, 3 and 6 months postpartum and every 6 months thereafter until the end of follow-up. The intervention group received enhanced HIV prevention counseling every 3 months throughout follow-up. The control group received standard counseling at the time of HIV retesting. Both intervention and control couples were offered couple HIV testing and counseling at all study visits. Main outcome measures Frequency of condom use and incidence of HIV, syphilis, gonorrhea, chlamydia and trichomoniasis over follow-up. Results Between February 2013 and April 2014, we enrolled 820 HIV-uninfected pregnant women presenting for antenatal care individually (n = 410) or in couples (n = 410 women and 410 partners) in one urban and one rural public Ugandan hospital. Women’s median age was 24 years (IQR 20–28 years). At baseline, participants did not differ in any socio-demographic, reproductive health, HIV testing history, sexual behavior, medical history or STI status characteristics; 96% (386/402) of couples were tested and counseled for HIV together with their partners at enrolment, 2.1% (7/329) of whom were found to be HIV-infected. Six hundred twenty-five (76%) women completed follow-up as per protocol (S1 Protocol). Women were followed for an average of 1.76 years and cumulated 1,439 women-years of follow-up or 81% of the maximum 1,779 women-years of follow-up assuming no dropouts. Men were followed for an average of 1.72 years. The frequency of consistent condom use and the proportion of women who used condoms over the last 3 months or at last vaginal sex increased substantially over follow-up in both arms, but there were no statistically significant differences in increases between the intervention and control arms. During follow-up, on average 42% (range 36%-46%) of couple partners were counseled together. Between 3.8% and 7.6% of women tested positive at any follow-up visit for any STI including syphilis, gonorrhea, C. trachomatis or T. vaginalis. Four women (two in each arm) and no enrolled men became infected with HIV, representing an overall HIV incidence rate of 0.186 per 100 person-years. Three of the women seroconverters had enrolled individually, one as a couple. At or before seroconversion, all four women reported their partners had extramarital relationships and/or had not disclosed their suspected HIV-infected status. There were no statistically significant differences between study arms for STI or HIV incidences. Conclusions A sustained enhanced HIV prevention counseling intervention for up to 2 years postpartum among pregnant and breastfeeding women did not have a statistically significant effect on condom use or HIV incidence among these women. However, in both study arms, condom use increased over follow-up while STI and HIV incidence remained very low when compared to similar cohorts in and outside Uganda, suggesting that repeat HIV testing during breastfeeding, whether with enhanced or standard counseling, may have had an unintended HIV preventive effect among pregnant and lactating women in this setting. Further research is needed to verify this hypothesis.
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U2 - 10.1371/journal.pone.0212119
DO - 10.1371/journal.pone.0212119
M3 - Article
C2 - 30802277
AN - SCOPUS:85062059853
VL - 14
JO - PLoS One
JF - PLoS One
SN - 1932-6203
IS - 2
M1 - e0212119
ER -