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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD070767-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This study aims to test the effectiveness of a behavioral intervention aimed at preventing the primary acquisition of HIV by uninfected pregnant and lactating women in Uganda, East Africa where HIV transmission is high. Women who acquire HIV during pregnancy or lactation are at higher risk of adverse health and pregnancy outcomes and their baby is at high risk of acquiring HIV and dying.
Keeping HIV-uninfected women uninfected during pregnancy and lactation is an important component of the global World Health Organization (WHO) strategy to eliminate mother-to-child transmission of HIV but there has been no study to date to assess interventions that can effectively keep these women uninfected.
In this study, the investigators will test the hypotheses that:
The specific aims of the study are:
We will conduct a stratified randomized trial of 410 HIV-negative pregnant Ugandan women enrolled individually and 410 HIV-negative pregnant women enrolled with their male partners in Mulago Hospital, Kampala and St Joseph Hospital, Kitgum, Northern Uganda. In each site, 205 women enrolled individually and 205 couples will be randomized to be either retested and counseled for HIV in late pregnancy only (>36 weeks) as per the WHO/Ministry of Health (MOH) recommendation, or to receive ERHTEC throughout pregnancy and breastfeeding.
Individual women and couples randomized to the intervention arm will receive the ERHTEC intervention at 3, 6, 12, and 18 months postpartum. Follow-up will end at 24 months postpartum or 6 weeks after the end of breastfeeding, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women-Extended Repeat Testing and Enhanced Counseling | Experimental | Pregnant/breastfeeding women enrolled individually and randomized to the intervention arm will receive extended repeat HIV testing and enhanced counseling at the time of labor and delivery and throughout the lactation period at 3, 6, 12, 18 and 24 months postpartum or until cessation of breastfeeding, whichever occurs first. |
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| Couples-Extended Repeat Testing and Enhanced Counseling | Experimental | Pregnant/breastfeeding women enrolled in couples with their male partners and randomized to the intervention arm will receive extended repeat HIV testing and enhanced counseling at the time of labor and delivery and throughout the lactation period at 3, 6, 12, 18 and 24 months postpartum or until cessation of breastfeeding, whichever occurs first. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended repeat HIV testing and enhanced counseling | Behavioral | Pregnant/breastfeeding women in the intervention arm and their male partners if present will receive extended repeat HIV testing and enhanced counseling around the time of labor and delivery and throughout the breastfeeding period. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of unprotected sex | Self-reported number of unprotected sex episodes among women participants validated by detection of semen (Y chromosome) in vaginal swabs | 27 months |
| Measure | Description | Time Frame |
|---|---|---|
| STI incidence | Incidence of Syphilis, N. gonorrhea, C. trachomatis and T. vaginalis infections among women and men participants | 27 months |
| HIV incidence | Incidence of HIV infection among women and men participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaco Homsy, MD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mulago Hospital | Kampala | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | King R, Bannink F, Mwambi K, Achiro S, Namusoke B, Ajok M, Oweka B, Akot C, Nalubega MG, Adengo M, Namukwaya Z, Homsy J. Primary prevention of HIV among pregnant and lactating women; the neglected PMTCT prong. 7th ICASA Conference, Cape Town, South Africa, 7-11 December 2013. Abstract 2420101. | ||
| 32414405 | Derived | Bannink Mbazzi F, Namukwaya Z, Amone A, Ojok F, Etima J, Byamugisha J, Katabira E, Fowler MG, Homsy J, King R; PRIMAL Study Team. "[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 women in the PRIMAL study, Uganda. BMC Public Health. 2020 May 15;20(1):694. doi: 10.1186/s12889-020-08738-x. | |
| 30802277 |
| Label | URL |
|---|---|
| Makerere University - Johns Hopkins University Research Collaboration | View source |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| 27 months |
| Incidence of recurrent wanted and unwanted pregnancy | Incidence of wanted and unwanted recurrent pregnancy within 24 months of delivery | 24 months |
| Derived |
| Homsy J, King R, Bannink F, Namukwaya Z, Vittinghof E, Amone A, Ojok F, Rukundo G, Amama S, Etima J, Matovu J, Weissglas F, Ojom L, Atim P, Darbes L, Byamugisha J, Rutherford G, Katabira E, Fowler MG; PRIMAL Study Team. Primary HIV prevention in pregnant and lactating Ugandan women: A randomized trial. PLoS One. 2019 Feb 25;14(2):e0212119. doi: 10.1371/journal.pone.0212119. eCollection 2019. |