Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HS 2648 | Other Identifier | Uganda national council of science and technology |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Infectious Diseases Research Collaboration, Uganda | OTHER |
| University of California, San Francisco | OTHER |
Not provided
Not provided
Not provided
Not provided
The ENHANCED -SPS study is a before and after cluster randomized trial that will be conducted in 14 public health facilities providing HIV care in Southwestern Uganda. The study will evaluate the effectiveness of a multi-component intervention package that targets barriers to achieving optimal viral suppression among pregnant and postpartum women infected with HIV. This will be in two phases; In Phase 1 ("Before"), all 14 clinics will have a baseline assessment of standard of care VL procedures and assess the barriers and facilitators to viral suppression for a period of 3 months. In Phase 2 ("After"), 7 clinics randomized to control arm will continue to experience standard of care counseling procedures, and 7 clinics randomized to intervention will initiate the ENHANCE-PS intervention. The Phase 2 ("After") phase I will last at least 12 months.
The Investigators will test the hypothesis that the Enhanced viral load (VL) counseling and standardized peer mother support (ENHANCED-SPS) intervention will increase viral load suppression among HIV-infected pregnant and post-partum women and increase retention of mothers in care hence resulting in reduced risk of vertical transmission in south western Uganda.
Specific objectives are as follows:
1) To evaluate the effectiveness of an enhanced VL counseling and standardized peer mother support intervention on viral suppression among HIV infected pregnant women at 12 months of follow up; 2) To evaluate the effect of the enhanced counseling and peer support intervention on retention in care at 18 months postpartum follow up; The investigators will randomize 14 HIV clinics to the ENHANCED-SPS multi-component intervention vs. standard of care procedures (intervention=7 clinics and control=7 clinics,n=70 mothers/health facility) ;3) To assess the facilitators and barriers of VL and enhanced VL counseling and peer mother support intervention at 9 & 18 months of follow up.This will consider both patient and providers perspectives of the intervention implementation
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | ENHANCED-SPS intervention implemented |
|
| Control | No Intervention | Standard of care maintained. These are procedures conducted during the routine HIV care visits at the health facilities include ART card documentation as required, general/routine counseling, and adherence counseling to the non suppressors, ART drug supply based on the clinicians prescription and laboratory monitoring. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENHANCED -SPS intervention | Behavioral | a) Enhanced VL counseling: Explanation of VL & Importance of VL suppression,assessment of adherence, counseling based on VL result and schedule for next VL testing and the role of VL and the MTCT risk; b).Standardized peer mother support: includes training of peer mothers on mandatory enhanced VL counseling during the routine peer counseling and education, follow up of mothers and continued adherence counseling and disclosure support and bi-weekly phone calls to mothers to provide VL counseling and follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Viral suppression | The proportion of women with HIV-1 RNA suppression at 12 months of follow up to assess the effect of the intervention | 1 year |
| Retention in care | The proportion of women still in care at at 12 and 18 months postpartum | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mother to child transmission rate | The proportion of HIV free children born to the HIV positive mothers enrolled in the study at 18 months of follow up. | 18 months |
Not provided
Inclusion Criteria:
All Pregnant women and breastfeeding mothers enrolled in the mother baby care points/HIV clinics with documented HIV infection
. HIV infected Pregnant women reporting for their first ANC within the study clinics or newly identified HIV positive mothers from the ANC clinics/breastfeeding
Exclusion Criteria:
. All women who will be critically ill and unable to communicate
. Those not willing to consent to participate in the study
. Women who will not be able to understand all information concerning the study
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jane Kabami, MPH | Contact | +256776411044 | kabajane@yahoo.com | |
| Moses Kamya, PhD | Contact | +256752900012 | mkamya@infocom.co.ug |
| Name | Affiliation | Role |
|---|---|---|
| Jane Kabami, MPH | Makerere University | Principal Investigator |
| Moses Kamya, PhD | Makerere University | Principal Investigator |
| Phillipa Musoke, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jane Kabami | Recruiting | Kampala | Mbarara | +256 | Uganda |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Comparative effectiveness cluster-randomized trial
Not provided
Not provided
Not provided
Not provided
|
| Makerere University |
| Principal Investigator |