Mother to Child HIV TransmissionIPOPNCT05017558
Evaluation of Measurement of Maternal Viral Load at Delivery to Optimise Post-natal Prophylaxis of HIV-exposed Newborns
An observational study of Mother to Child HIV Transmission, run by ANRS, Emerging Infectious Diseases at 1 site in Guinea.
Trial summary
The main objective is to evaluate the operationality of introducing the measurement of viral load in HIV-1 infected mothers at delivery by POC to optimise post-natal prophylaxis and neonatal diagnosis of children according to the estimated risk of MTCT (high risk: HIV viral load (VL) at delivery ≥ 1000 copies/mL, low… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mother to Child HIV Transmission
- What is being tested?
- point of care
- How many people
- 70 participants
- Where
- 1 siteGuinea
- Study dates
- 3 Mar 2023to 12 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Measurement of viral load in HIV-1 infected mothers at delivery by POC to optimise post-natal prophylaxis and neonatal diagnosis of children according to the estimated risk of MTCT (high risk:VL at delivery ≥ 1000 copies/mL, low risk: VL at delivery < 1000 copies/mL) in Conakry, Guinea.
Who may be able to join
- For mother:
- Mother/child couple whose mother is HIV-1 infected, whether or not the infection is known and treated at delivery
- Mother of full age 18 years or older
- Mother agreeing to be contacted by telephone to ensure that appointments are respected.
- Mother has signed the informed consent form to participate in the study (and agrees to be followed, along with her child, at the centre for the duration of the study).
- For children:
- Live newborn baby
- Free, informed and written consent must be signed by the holder(s) of parental authority and the investigator for the child's participation in this research (at the latest on the day of birth and before any intervention carried out on the newborn in the trial).
Who cannot join
- For mother:
- Mother infected with HIV-2
- Not included due to monitoring difficulties:
- Anticipated absence(s) that could hinder participation in research (travel abroad, relocation, travel);
- Insufficient motivation to be followed for 9 months in the centre.
- No mobile phone or refusal to be called by investigators if necessary.
Show all 10Show fewer
- Mother and/or children already participating in another biomedical study
- For children:
- Not included for reasons of caution (child with severe congenital malformation or clinical symptomatology suggesting opportunistic infection).
- The child has a known allergy to the drug given as part of HIV prophylaxis in Guinea or to its components.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Operational Evaluation of the Introduction of "Point Of Care" (POC) to Optimise Post-natal Prophylaxis of HIV-exposed Newborns According to the Risk of Maternal to Child Transmission (MTCT) Assessed by Measuring Maternal Viral Load at Delivery in Conakry, Guinea
The main objective is to evaluate the operationality of introducing the measurement of viral load in HIV-1 infected mothers at delivery by POC to optimise post-natal prophylaxis and neonatal diagnosis of children according to the estimated risk of MTCT (high risk: HIV viral load (VL) at delivery ≥ 1000 copies/mL, low risk: VL at delivery < 1000 copies/mL) in Conakry, Guinea.
Read the detailed description
Intervention:
All women screened for HIV-1 infection in the delivery room, whether or not the infection was previously known, whether or not they are treated, will be eligible to participate in this study and will be offered inclusion in the study.
The women will benefit from a viral load measurement by POC (Cepheid GenXpert HIV-1 viral load) at the time of delivery.
Newborns will benefit :
- the provision of antiretroviral (ARV) preventive treatment differentiated according to their risk of infection in accordance with national recommendations:
- High risk (maternal VL ≥1000 cp/ml): zidovudine (AZT)/ nevirapine (NVP) for 12 weeks.
- Low risk (maternal VL <1000 cp/ml): NVP for 6 weeks.
- early and regular virological screening for HIV by qualitative POC (Cepheid GenXpert HIV-1 qual) from birth (for high-risk newborns) at 6 weeks, at 9 months and at any time in the event of clinical manifestations suggestive of HIV infection.
- In the event of a positive HIV test, the child will initiate immediate antiretroviral treatment combining zidovudine (AZT)/ lamivudine (3TC)/ Lopinavir-retonivir (LPV/r) and a confirmatory test will be done by POC (Cepheid GenXpert HIV-1 viral load) according to World Health Organisation (WHO) and national recommendations.
- support from the project team and peers, volunteers from the association Fédération Espoir Guinée (FEG), to improve retention in care and compliance of mother and child, promotion of exclusive breastfeeding for 6 months and family nutritional support, Cotrimoxazole (CTX) prophylaxis and the Expanded Programme on Immunization will be provided by the national programme.
- Conditions
- Mother to Child HIV Transmission
- Being tested
- point of care
- Keywords
- prevention of mother to child HIV transmission, HIV early diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
point of careDiagnostic test
HIV-1 infected women will benefit from a viral load measurement by POC (Cepheid GenXpert HIV-1 viral load) at the time of delivery.
Newborns will benefit :
- Antiretroviral preventive treatment differentiated according to their risk of infection in accordance with national recommendations:
- High risk (maternal VL ≥1000 cp/ml): AZT/NVP for 12 weeks.
- Low risk (maternal VL <1000 cp/ml): NVP for 6 weeks.
- virological screening for HIV by qualitative POC (Cepheid GenXpert HIV-1 qual) from birth (for high-risk newborns) at 6 weeks, at 9 months and at any time in the event of clinical manifestations suggestive of HIV infection.
- In the event of a positive HIV test, the child will initiate immediately AZT/3TC/LPV/r
- support from volunteers to improve retention in care, promotion of exclusive breastfeeding and family nutritional support
| Study group | Role | What they receive |
|---|---|---|
| intervention | Measurement of viral load in HIV-1 infected mothers at delivery by POC to optimise post-natal prophylaxis and neonatal diagnosis of children according to the estimated risk of MTCT (high risk:VL at delivery ≥ 1000 copies/mL, low risk: VL at delivery < 1000 copies/mL) in Conakry, Guinea. Receives: Diagnostic Test: point of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the operationally of introducing the measurement of viral load in HIV-1 infected mothers at delivery by POC
Proportion of newborns having received antiretroviral prophylaxis within 48 hours after delivery adapted to the "real" risk of MTCT, defined by measuring the maternal viral load by POC at delivery.
Measured: Day 0 to day 2
Secondary outcomes (25)
To evaluate the intrinsic diagnostic performance of viral load measurement by POC Xpert HIV-1 in comparison with the evaluation of the level of risk by maternal interrogation alone.
Sensitivity and specificity of the risk level assessment by the interrogation data in comparison with viral load measurement as a reference method.
Defining the level of risk through interrogation :
- High risk: newborn of an HIV-infected mother who is not treated with antiretroviral (ARV) within 4 weeks before delivery and/or who discovers HIV infection at delivery;
- Low risk: newborn of HIV-infected mother treated with ARV since ≥ 4 weeks before delivery).
Defining the level of risk by measuring HIV viral load:
- High risk: VL>1000 cp/mL
- Low risk: VL≤ 1000 cp/mL
Measured: Day 0 to day 2
To assess the proportion of women who received Xpert HIV-1 viral load test at delivery.
Proportion of women who received Xpert HIV-1 viral load test at delivery.
Measured: Day 0 to day 2
To assess the turn around time of Xpert HIV-1viral load
Total time (day) from sampling to result of Xpert HIV-1 viral load test performed at delivery
Measured: Day 0 to day 2
To measure the satisfaction of health care staff and mothers with the use of the POC test to monitor viral load in mothers.
Measure, through a questionnaire, the satisfaction of health workers and mothers with the use of the POC test to monitor viral load in mothers. for mothers the questionnaires will be analyzed on a scale of 0 to 25 , with a score of 25 corresponding to maximum satisfaction. For health workers the questionnaires will be analyzed on a scale of 8 to 32, with a score of 32 corresponding to maximum satisfaction.
Measured: Day 0 to day 2
To assess the proportion of children who received Xpert HIV-1 qual test
Proportion of children who received Xpert HIV-1 qual test at birth for children at high risk, and at week 6 and week 9 for all children
Measured: Day 0 to week 9
To assess the turn around time of Xpert HIV-1 qual test
Total time (day) from sampling to result of Xpert HIV-1 qual test at birth for children at high risk, and at week 6 and week 9 for all children
Measured: Day 0 to week 9
To measure the satisfaction of health care workers and mothers with the use of the POC test for early infant diagnosis.
Measure, through a questionnaire, the satisfaction of health workers and mothers with the use of the POC test to monitor viral load in mothers. for mothers the questionnaires will be analyzed on a scale of 0 to 25 , with a score of 25 corresponding to maximum satisfaction. For health workers the questionnaires will be analyzed on a scale of 8 to 32, with a score of 32 corresponding to maximum satisfaction.
Measured: Day 0 to week 9
To collect feedback from health professionals and mothers on the use of POC in the clinic.
collect feedback from health professionals and mothers on the use of POC in the clinic, during individual interview at the end of the study.
Measured: Day 0 to week 9
To assess the proportion of women ready to start or continue ARV treatment ("ARV readiness") during the study, comparing the proportion of women lost to follow-up from day 0 to month 9.
Measure the proportion of women ready to start or continue ART ("ARV readiness") during the study using a questionnaire, comparing the proportion of women lost to follow-up from day 0 to month 9.
The questionnaires will be analyzed on a scale of 5 to 25, with a score of 25 corresponding to the highest readiness to initiate the treatment.
Measured: Day 0 to month 9
To determine whether the stigma of the women included in the study affects the proportion lost to follow-up during the study.
Determine using a questionnaire administered at 6 weeks whether stigma of the women included in the study affects the proportion lost to follow-up during the study, by comparing data from month 3 and month 9 to week 6. The questionnaires will be analyzed on a scale of 0 to 13, with a score of 13 corresponding to maximum stigmatisation level.
Measured: Week 6 to month 9
To assess the proportion of untreated women initiating ARV treatment
Proportion of untreated women initiating ARV treatment at day 0 at the time of delivery
Measured: Day 0 to day 2
To assess the proportion of women lost to follow-up
Proportion of HIV-1 infected women lost to follow-up between day 0 and month 9
Measured: Day 0 to month 9
To assess the proportion of HIV-1 infected women with virological success
Proportion of mothers whose HIV viral load is <1000 cp/mL and <50 cp/mL at month 6
Measured: Month 6
To assess the proportion of children lost to follow-up
Proportion of children lost to follow-up from day 0 to month 9
Measured: Day 0 to month 9
To assess the proportion of HIV-1 infected children initiating ARV treatment
Proportion of children with a diagnosis of HIV infection made between day 0 and month 9, initiating ARV treatment.
Measured: Day 0 to month 9
To assess the turn around time from from sample collection to ARV treatment initiation in HIV-1 infected children
Delay between sample collection and initiation of ARV treatment in the case of diagnosis of HIV infection in children from day 0 to month 9.
Measured: Day 0 to month 9
To assess the rate of mother-to-child transmission of HIV
Proportion of HIV-infected children between day 0 and month 9 among children followed from day 0 to month 9 whose HIV status is known.
Measured: Day 0 to month 9
To assess the proportion of women practicing exclusive breastfeeding.
Proportion of women reporting exclusive breastfeeding up to month 6.
Measured: Day 0 to month 6
To measure, in women with a VL<1000 cp/mL at delivery who do not report taking ARV, the proportion of those with ARV detectable in the plasma and the nature of those ARV detected.
Proportion of women with VL <1000 and reporting not taking ARV, having ARV detectable in plasma and the nature of these ARV
Measured: Day 0 to day 2
To measure, in women with a VL>1000 cp/mL at delivery and reporting taking ARV, the proportion of those with ARV detectable in the plasma and the nature of these ARV detected.
Proportion of women with VL ≥1000 at delivery and reporting taking ARV, having plasma-detectable ARVs and the nature of these ARV
Measured: Day 0 to day 2
To measure the proportion of women reporting taking ARV before childbirth and having a detectable VL at delivery, the proportion of viruses with ARV resistance mutations.
Proportion of women with detectable VL (≥ 50 cp/mL) at delivery whose virus has ARV resistance mutations and the nature of these mutations.
Measured: Day 0 to day 2
To measure the proportion of HIV-infected children with ARV resistance mutations.
Proportion of children infected with HIV whose virus has ARV resistance mutations and the nature of these mutations.
Measured: Day 0 to month 9
Assess patient adherence to ARV treatment on the basis of adherence questionnaires from day 0 to months 9
Proportion of women on ARV treatment reporting less than 2 uptake left per week on day 0 (for women on pre-delivery treatment only), month 3, month 6 and months 9.
Measured: Day 0 to 9 month 9
Assess patient adherence to ARV treatment on the basis of ARV dosage at day 0 (only for mothers treated before delivery) and at month 6.
Proportion of patients on treatment in whom ARV were detected in plasma at effective residual concentration at day 0 (for women on treatment before delivery only), and at month 6.
Measured: Day 0 to month 6
Socio-anthropological survey: Assessment of feelings about the study among mothers, fathers, psychosocial counsellors and health professionals.
Evaluation, by means of individual interviews at the end of the study, of the feelings of mothers, fathers, psychosocial counsellors and health professionals about the study.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start3 Mar 2023
- Primary completion12 Dec 2024
- Study completion12 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mother to Child HIV TransmissionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017558
- Sponsor's protocol ID
- ANRS12412 IPOP
- Acronym
- IPOP
- Status last verified
- Oct 2026
- First submitted
- 19 Jul 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operational Evaluation of the Introduction of "Point Of Care" (POC) to Optimise Post-natal Prophylaxis of HIV-exposed Newborns According to the Risk of Maternal to Child Transmission (MTCT) Assessed by Measuring Maternal Viral Load at Delivery in Conakry, Guinea
- ClinicalTrials.gov ID
- NCT05017558
- Acronym / sponsor ID
- IPOP / ANRS12412 IPOP
- Conditions
- Mother to Child HIV Transmission
- Keywords
- prevention of mother to child HIV transmission, HIV early diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Apr 2026 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to evaluate the operationality of introducing the measurement of viral load in HIV-1 infected mothers at delivery by POC to optimise post-natal prophylaxis and neonatal diagnosis of children according to the estimated risk of MTCT (high risk: HIV viral load (VL) at delivery ≥ 1000 copies/mL, low risk: VL at delivery < 1000 copies/mL) in Conakry, Guinea.
Detailed description
Intervention:
All women screened for HIV-1 infection in the delivery room, whether or not the infection was previously known, whether or not they are treated, will be eligible to participate in this study and will be offered inclusion in the study.
The women will benefit from a viral load measurement by POC (Cepheid GenXpert HIV-1 viral load) at the time of delivery.
Newborns will benefit :
- the provision of antiretroviral (ARV) preventive treatment differentiated according to their risk of infection in accordance with national recommendations:
- High risk (maternal VL ≥1000 cp/ml): zidovudine (AZT)/ nevirapine (NVP) for 12 weeks.
- Low risk (maternal VL <1000 cp/ml): NVP for 6 weeks.
- early and regular virological screening for HIV by qualitative POC (Cepheid GenXpert HIV-1 qual) from birth (for high-risk newborns) at 6 weeks, at 9 months and at any time in the event of clinical manifestations suggestive of HIV infection.
- In the event of a positive HIV test, the child will initiate immediate antiretroviral treatment combining zidovudine (AZT)/ lamivudine (3TC)/ Lopinavir-retonivir (LPV/r) and a confirmatory test will be done by POC (Cepheid GenXpert HIV-1 viral load) according to World Health Organisation (WHO) and national recommendations.
- support from the project team and peers, volunteers from the association Fédération Espoir Guinée (FEG), to improve retention in care and compliance of mother and child, promotion of exclusive breastfeeding for 6 months and family nutritional support, Cotrimoxazole (CTX) prophylaxis and the Expanded Programme on Immunization will be provided by the national programme.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | – | Diagnostic Test: point of careMeasurement of viral load in HIV-1 infected mothers at delivery by POC to optimise post-natal prophylaxis and neonatal diagnosis of children according to the estimated risk of MTCT (high risk:VL at delivery ≥ 1000 copies/mL, low risk: VL at delivery < 1000 copies/mL) in Conakry, Guinea. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Measurement of viral load in HIV-1 infected mothers at delivery by POC to optimise post-natal prophylaxis and neonatal diagnosis of children according to the estimated risk of MTCT (high risk:VL at delivery ≥ 1000 copies/mL, low risk: VL at delivery < 1000 copies/mL) in Conakry, Guinea.
Key inclusion criteria (8 listed)
- For mother:
- Mother/child couple whose mother is HIV-1 infected, whether or not the infection is known and treated at delivery
- Mother of full age 18 years or older
- Mother agreeing to be contacted by telephone to ensure that appointments are respected.
- Mother has signed the informed consent form to participate in the study (and agrees to be followed, along with her child, at the centre for the duration of the study).
Key exclusion criteria (10 listed)
- Mother infected with HIV-2
- Not included due to monitoring difficulties:
- Mother and/or children already participating in another biomedical study
- Not included for reasons of caution (child with severe congenital malformation or clinical symptomatology suggesting opportunistic infection).
- The child has a known allergy to the drug given as part of HIV prophylaxis in Guinea or to its components.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| point of careHIV-1 infected women will benefit from a viral load measurement by POC (Cepheid GenXpert HIV-1 viral load) at the time of delivery. Newborns will benefit : 1. Antiretroviral preventive treatment differentiated according to their risk of infection in accordance with national recommendations: * High risk (maternal VL ≥1000 cp/ml): AZT/NVP for 12 weeks. * Low risk (maternal VL <1000 cp/ml): NVP for 6 weeks. 2. virological screening for HIV by qualitative POC (Cepheid GenXpert HIV-1 qual) from birth (for high-risk newborns) at 6 weeks, at 9 months and at any time in the event of clinical manifestations suggestive of HIV infection. 3. In the event of a positive HIV test, the child will initiate immediately AZT/3TC/LPV/r 4. support from volunteers to improve retention in care, promotion of exclusive breastfeeding and family nutritional support | Diagnostic test | intervention |
Primary outcome
Evaluate the operationally of introducing the measurement of viral load in HIV-1 infected mothers at delivery by POC
Time frame: Day 0 to day 2
Proportion of newborns having received antiretroviral prophylaxis within 48 hours after delivery adapted to the "real" risk of MTCT, defined by measuring the maternal viral load by POC at delivery.
25 secondary outcomes
To evaluate the intrinsic diagnostic performance of viral load measurement by POC Xpert HIV-1 in comparison with the evaluation of the level of risk by maternal interrogation alone.
Time frame: Day 0 to day 2
To assess the proportion of women who received Xpert HIV-1 viral load test at delivery.
Time frame: Day 0 to day 2
To assess the turn around time of Xpert HIV-1viral load
Time frame: Day 0 to day 2
To measure the satisfaction of health care staff and mothers with the use of the POC test to monitor viral load in mothers.
Time frame: Day 0 to day 2
To assess the proportion of children who received Xpert HIV-1 qual test
Time frame: Day 0 to week 9
To assess the turn around time of Xpert HIV-1 qual test
Time frame: Day 0 to week 9
To measure the satisfaction of health care workers and mothers with the use of the POC test for early infant diagnosis.
Time frame: Day 0 to week 9
To collect feedback from health professionals and mothers on the use of POC in the clinic.
Time frame: Day 0 to week 9
To assess the proportion of women ready to start or continue ARV treatment ("ARV readiness") during the study, comparing the proportion of women lost to follow-up from day 0 to month 9.
Time frame: Day 0 to month 9
To determine whether the stigma of the women included in the study affects the proportion lost to follow-up during the study.
Time frame: Week 6 to month 9
To assess the proportion of untreated women initiating ARV treatment
Time frame: Day 0 to day 2
To assess the proportion of women lost to follow-up
Time frame: Day 0 to month 9
To assess the proportion of HIV-1 infected women with virological success
Time frame: Month 6
To assess the proportion of children lost to follow-up
Time frame: Day 0 to month 9
To assess the proportion of HIV-1 infected children initiating ARV treatment
Time frame: Day 0 to month 9
To assess the turn around time from from sample collection to ARV treatment initiation in HIV-1 infected children
Time frame: Day 0 to month 9
To assess the rate of mother-to-child transmission of HIV
Time frame: Day 0 to month 9
To assess the proportion of women practicing exclusive breastfeeding.
Time frame: Day 0 to month 6
To measure, in women with a VL<1000 cp/mL at delivery who do not report taking ARV, the proportion of those with ARV detectable in the plasma and the nature of those ARV detected.
Time frame: Day 0 to day 2
To measure, in women with a VL>1000 cp/mL at delivery and reporting taking ARV, the proportion of those with ARV detectable in the plasma and the nature of these ARV detected.
Time frame: Day 0 to day 2
To measure the proportion of women reporting taking ARV before childbirth and having a detectable VL at delivery, the proportion of viruses with ARV resistance mutations.
Time frame: Day 0 to day 2
To measure the proportion of HIV-infected children with ARV resistance mutations.
Time frame: Day 0 to month 9
Assess patient adherence to ARV treatment on the basis of adherence questionnaires from day 0 to months 9
Time frame: Day 0 to 9 month 9
Assess patient adherence to ARV treatment on the basis of ARV dosage at day 0 (only for mothers treated before delivery) and at month 6.
Time frame: Day 0 to month 6
Socio-anthropological survey: Assessment of feelings about the study among mothers, fathers, psychosocial counsellors and health professionals.
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mother to Child HIV Transmission, run by ANRS, Emerging Infectious Diseases at 1 site in Guinea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the operationally of introducing the measurement of viral load in HIV-1 infected mothers at delivery by POC (time frame: Day 0 to day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.