Trial · NCT03431168
A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV
NCT03431168, Phase 2, Completed, University of Alabama at Birmingham; results first posted 2022-05-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV. Trials, record NCT03431168. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03431168
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV
- NCT number
- NCT03431168
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 308 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- HIV, Pregnancy Malaria, Sexually Transmitted Infection
- Interventions
- Azithromycin/TMPS, Placebo/TMPS
- First posted
- 2018-02-13
- Last updated
- 2023-11-27
- Results first posted
- 2022-05-04
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasmodium Falciparum Peripheral Parasitemia | At end of pregnancy (>35 weeks) or at delivery | P. falciparum detected by microscopy or polymerase chain reaction (PCR) |
| Primary | Proportion With Composite STI Outcome | will be measured in both groups (>35 weeks) or at delivery | Including chlamydia (NAAT (nucleic acid amplification test) positive) , gonorrhea (NAAT positive), syphilis (non-treponemal and treponemal test positive) infections. |
| Secondary | Low Birthweight (<2500 Grams) | at birth | Neonatal weight measured with digital scale |
| Secondary | Proportion With Adverse Birth Outcomes | Birth outcomes will be measured at birth for all outcomes except early neonatal mortality defined as within 7 days of birth. Early neonatal mortality will be assessed at a six week follow up phone call. | Composite measure: low infant birthweight (\<2500 grams), miscarriage (\<28 weeks), preterm delivery (\<37 weeks), small for gestational age (SGA), congenital anomaly detected on surface examination, early neonatal mortality (within 7 days of birth) |
| Secondary | Maternal Adherence to the Prophylactic Regimen | Adherence of study medication taken at home will be documented from the date of randomization until the time of delivery, assessed up to 42 weeks. | Directly observed therapy (DOT) in clinic for the 1st dose of study medication. Self-report and pill count will be used to assess adherence and maternal tolerability for study medications taken at home from the time of enrollment until delivery. At each follow up visit and at delivery, participants will complete a medication adherence survey. They will self-report adherence to the 3 day study regimen (AZ or placebo). |
| Secondary | Proportion of Participants With Symptomatic Malaria | From the date of randomization until the time of delivery, assessed up to 42 weeks. | Fever and positive malaria test (rapid diagnostic test) at routine visits or sick call visits or maternal report of malaria diagnosis. |
| Secondary | Proportion With Placental Malaria | At delivery | Placentas will be collected on a subset of women and impression smear will be used to assess for malaria infection |
| Secondary | Proportion With Maternal Anemia and Severe Maternal Anemia | At the end of pregnancy (>35 weeks) or at delivery | anemia defined as hemoglobin \<11 g/dL, severe anemia defined as hemoglobin \<7 g/dL. |
| Secondary | Composite STI Measure (Including All STI Tests) | After 35 weeks GA or at delivery | Proportion of women with GC/CT (by NAAT), syphilis (by serology), Mycoplasma genitalium (NAAT). |
| Secondary | GBS Colonization | at or near term or at delivery | anogenital GBS colonization detected by NAAT (PCR) |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Plasmodium Falciparum Peripheral Parasitemia | At end of pregnancy (>35 weeks) or at delivery | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Proportion With Composite STI Outcome | will be measured in both groups (>35 weeks) or at delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Low Birthweight (<2500 Grams) | at birth | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion With Adverse Birth Outcomes | Birth outcomes will be measured at birth for all outcomes except early neonatal mortality defined as within 7 days of birth. Early neonatal mortality will be assessed at a six week follow up phone call. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Maternal Adherence to the Prophylactic Regimen | Adherence of study medication taken at home will be documented from the date of randomization until the time of delivery, assessed up to 42 weeks. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Participants With Symptomatic Malaria | From the date of randomization until the time of delivery, assessed up to 42 weeks. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion With Placental Malaria | At delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion With Maternal Anemia and Severe Maternal Anemia | At the end of pregnancy (>35 weeks) or at delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Composite STI Measure (Including All STI Tests) | After 35 weeks GA or at delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | GBS Colonization | at or near term or at delivery | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Plasmodium Falciparum Peripheral Parasitemia | Azithromycin/TMPS | 8 | Participants | ||
| Plasmodium Falciparum Peripheral Parasitemia | Placebo/TMPS | 7 | Participants | ||
| Proportion With Composite STI Outcome | Azithromycin/TMPS | 2 | Participants | ||
| Proportion With Composite STI Outcome | Placebo/TMPS | 2 | Participants | ||
| Low Birthweight (<2500 Grams) | Azithromycin/TMPS | 4 | Participants | ||
| Low Birthweight (<2500 Grams) | Placebo/TMPS | 7 | Participants | ||
| Proportion With Adverse Birth Outcomes | Azithromycin/TMPS | 13 | Participants | ||
| Proportion With Adverse Birth Outcomes | Placebo/TMPS | 20 | Participants | ||
| Maternal Adherence to the Prophylactic Regimen | Azithromycin/TMPS | 148 | Participants | ||
| Maternal Adherence to the Prophylactic Regimen | Placebo/TMPS | 148 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Azithromycin/TMPS | 155 | |
| Overall Study | STARTED | Placebo/TMPS | 153 | |
| Overall Study | COMPLETED | Azithromycin/TMPS | 132 | |
| Overall Study | COMPLETED | Placebo/TMPS | 129 | |
| Overall Study | NOT COMPLETED | Azithromycin/TMPS | 23 | |
| Overall Study | NOT COMPLETED | Placebo/TMPS | 24 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Azithromycin/TMPS | 0 | 155 |
| Total, all-cause mortality | Placebo/TMPS | 0 | 153 |
| Total, other adverse events | Azithromycin/TMPS | 0 | 155 |
| Total, other adverse events | Placebo/TMPS | 0 | 153 |
| Total, serious adverse events | Azithromycin/TMPS | 0 | 155 |
| Total, serious adverse events | Placebo/TMPS | 0 | 153 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39324693 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons12
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Azithromycin/TMPS vs Placebo/TMPS: Plasmodium Falciparum Peripheral Parasitemia | Trial comparisons |
| Azithromycin/TMPS vs Placebo/TMPS: Maternal Adherence to the Prophylactic Regimen | Trial comparisons |
| Azithromycin/TMPS vs Placebo/TMPS: GBS Colonization | Trial comparisons |
| Azithromycin/TMPS vs Placebo/TMPS: Composite STI Measure (Including All STI Tests) | Trial comparisons |
| Azithromycin/TMPS vs Placebo/TMPS: Proportion With Placental Malaria | Trial comparisons |
| Azithromycin/TMPS vs Placebo/TMPS: Proportion With Adverse Birth Outcomes | Trial comparisons |
| Azithromycin/TMPS vs Placebo/TMPS: Proportion of Participants With Symptomatic Malaria | Trial comparisons |
| Azithromycin/TMPS vs Placebo/TMPS: Proportion With Maternal Anemia and Severe Maternal Anemia | Trial comparisons |
| Azithromycin/TMPS vs Placebo/TMPS: deaths from any cause | Trial comparisons |
| Azithromycin/TMPS vs Placebo/TMPS: Low Birthweight (<2500 Grams) | Trial comparisons |
1 to 10 of 12
See all 12 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03431168
GET https://conductscience.org/api/trials/v1/NCT03431168/registered