Primary HIV prevention in pregnant and lactating Ugandan women: A randomized trial

Abstract

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. Betwe...

“[ Repeat ] testing and counseling is one of the key [ services ] that the government should continue providing”: Participants’ Perceptions on Extended Repeat HIV Testing and Enhanced Counseling (ERHTEC) for Primary HIV Prevention in Pregnant and Lactating Ugandan Women

“…This qualitative study showed that participants did feel more knowledgeable and empowered to negotiate sex and condom use. While the PRIMAL study did not find a significant statistical effect of the ERHTEC intervention in increasing condom use or in reducing HIV or STI incidence among HIVuninfected pregnant and lactating Ugandan women, condom use did increase significantly over follow-up in both arms and both groups (individually enrolled women or couples) of the study [9]. This is in line with earlier reports on a slow increase of condom use amongst married couples in Uganda [22][23][24].…”

“…The counselling increased understanding among couples, improved communication, and resulted in more joined decision-making including negotiation about sex and condom use. Although no significant differences were found in the quantitative study in either condom use increase or in HIV and STI incidence over follow-up, the low annual HIV incidence rate of 0.278 per 100 women years of follow-up that characterized the entire study cohort of men and women over an average of 21 months of follow-up is in line with the risk reduction effect participants perceived through the EHRTEC intervention [9].…”

“…The hypotheses were that; 1) extended repeat HIV testing and enhanced counseling (HTC) during late pregnancy and throughout breastfeeding can increase and sustain risk reduction behaviors and prevent incident STI and HIV infections among HIV-uninfected pregnant women, and 2) that couple HTC can further enhance this effect through improved couple communication and emotional and economic support from male partners. The results of the RCT showed that condom use increased but not significantly differently in intervention and control arms of the trial, and that the incidence of STIs and HIV among this cohort remained very low in follow-up in both the intervention and control groups in contrast with comparable population-based Ugandan cohorts [9].…”

“…increases uptake of HIV prevention and care services and identification of HIV sero-discordant couples [6][7][8]. The 'Primary HIV Prevention among Pregnant and Lactating Ugandan Women' (PRIMAL) randomized controlled trial (RCT) assessed the effect of the enhanced counseling component effects of an extended repeat HIV testing and enhanced counseling (ERHTEC) intervention on 410 HIVnegative pregnant and lactating women and 205 of their male partners compared to an equal number of controls on risk reduction behavior and the risk of STI and HIV acquisition by these mothers during late pregnancy and throughout the breastfeeding period [9]. In each arm of the trial, half of the participants were enrolled individually and the other half were enrolled with their partner (as couples)…”

“…The PRIMAL study has been described in detail elsewhere [9]. Briefly, it enrolled 820 HIV-negative pregnant women and 410 of their male partners from the antenatal care (ANC) clinics of Mulago National Referral Hospital in Uganda's capital city of Kampala, and of St Joseph's Hospital in the small rural town of Kitgum, Northern Uganda, 430 kms north of Kampala.…”