Human Immunodeficiency Virus (HIV)EPICNCT02027714
Enhanced HIV Prevention in Couples: Feasibility Study #1
An observational study of Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS), run by Columbia University at 4 sites in Lesotho.
Trial summary
The purpose of this study is to gather information needed to develop a large prevention trial to decrease the risk for HIV transmission among HIV-discordant couples (where one person is HIV-positive and the other is HIVnegative) in Lesotho. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Human Immunodeficiency Virus (HIV), Acquired Immune Deficiency Syndrome (AIDS)
- How many people
- 230 participants
- Where
- 4 sitesLesotho
- Study dates
- Apr 2011to May 2014
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Pregnant and postpartum women within 6 months of delivery and men will be enrolled. This feasibility study is targeting women seeking care in ANCs as these clinics are where large numbers of women learn their HIV status and become engaged in HIV prevention and/or care and treatment services. It is through these women that men from the community will be recruited for participation in the study.
Who may be able to join
- Women's Quantitative Survey
- Women at least 18 years of age
- Pregnant or within 6 months postpartum
- Receiving antenatal care at target clinic
- Ability to speak English or Sesotho
- Women's Focus Group Discussion
Show all 15Show fewer
- All inclusion criteria listed in Women's Quantitative Survey AND
- Ability to speak Sesotho, specifically
- Willingness to disclose HIV status within FGD
- Willingness to allow audio- recording of FGD
- Male Individual Interviews
- Men between 18 and 50 years of age
- Living or working in one of the two targeted districts
- Ability to speak Sesotho
- Willingness to allow audio- recording of interview
Who cannot join
- Individuals meeting any of the exclusion criteria will be excluded from study participation.
- For all quantitative and qualitative components
- Individuals who do not meet the inclusion criteria outlined above
- Any condition which in the opinion of the investigators would interfere with adherence to study requirements
Trial locations and contacts
4 sites in 1 country.
Lesotho4 sites
Le'Coop Health Center
Mafeteng
Mafeteng District Hospital
Mafeteng
Mpharane Clinic
Mohale's Hoek
Ntsekhe Hospital
Mohale's Hoek
About this study
Official title: Enhanced HIV Prevention in Discordant Couples in Lesotho: Feasibility Study #1
The purpose of this study is to gather information needed to develop a large prevention trial to decrease the risk for HIV transmission among HIV-discordant couples (where one person is HIV-positive and the other is HIVnegative) in Lesotho. The protocol team would like to learn more about men, women and couples in Lesotho and what they think about various topics related to HIV, including HIV testing and counseling, male circumcision and HIV treatment.
There will be three parts to the study including 1) a survey 2) focus group discussions; and 3) in-depth interviews. Two hundred pregnant or recently postpartum women will be recruited to participate in the survey. Women who answer the questionnaire will also be asked to participate in the focus groups. A total of 6-8 groups consisting of 6-12 women each will be conducted. Thirty men from the community will be recruited to participate in an in-depth individual interview.
Read the detailed description
Studies to date indicate that HIV negative partners within HIV-discordant couples (where one partner is HIV+ and the other is HIV-) are at substantial risk of acquiring HIV infection and that such transmission may play animportant role in heterosexual transmission of HIV in countries with high seroprevalence in sub-Saharan Africa. The purpose of this study is to conduct preparatory research needed to design and implement an HIV-prevention intervention trial aimed at decreasing the risk for HIV infection among HIV-discordant couples in Lesotho.
Using both quantitative and qualitative research methods, the study aims to:
- Establish baseline characteristics of the proposed study population, specifically pregnant and recently postpartum women and of men in Lesotho
- Explore the types of sexual and social relationships that exist between men and women in Lesotho
- Assess individual knowledge, understanding and perceptions around different HIV prevention strategies, including HIV testing and treatment, couples counseling and male circumcision
- Identify interpersonal and individual-level barriers to accessing these types of HIV prevention interventions.
There will be three study components including 1) quantitative survey 2) focus group discussions; and 3) in-depth individual interviews. A quantitative cross-sectional survey will be administered to 200 pregnant and recently postpartum women. Qualitative components will be based on open-ended iterative inquiry via focus group discussions and in-depth interviews with two groups: (1) pregnant and recently postpartum women; and (2) men. Data gathered during this study will inform the study design and intervention components of the proposed prevention intervention study.
- Keywords
- Discordant, Lesotho, Couples, Enhanced Prevention Package (EPP), ART, Counseling, Male Circumcision
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women's Quantitative Survey | Quantitative surveys will be administered to 200 pregnant and recently postpartum women. Surveys will be conducted in either English or Sesotho depending on the participant's preference. Surveys will be administered by a study-staff member. Survey activities will be conducted in a private space either within or around the clinic building. All study activities will take approximately 1 hour to complete. The survey is comprised of 62 close-ended questions. Included in this survey are questions related to demographics, sexual behaviors, HIV and various HIV testing services. | |
| Women's Focus Group Discussions | 6-8 focus groups of approximately 6-12 pregnant or recently postpartum women will be conducted. Focus group discussions will be organized according to HIV serostatus to allow for open dialogue and participant comfort. All group discussions will be conducted in Sesotho. Each group discussion will be facilitated, preferably, by a female study-staff member. All group discussions will be held in a private space either within a study site or another specified location within the community. All study activities will take approximately two hours to complete. Topics that will be discussed during these interviews include relationship dynamics between Basotho men and women, knowledge of HIV and various related issues, including HIV testing, HIV treatment and discordancy in HIV status. Additionally, questions about knowledge and attitudes regarding male circumcision will be asked. | |
| Male Interviews | 30 in-depth individual interviews with men. In-depth semi structured interviews consisting of open-ended questions will be conducted in either English or Sesotho depending on the participant's preference will be conducted. Interview activities will be conducted in a private space either within or around the clinic building. Topics that will be discussed during these interviews include relationship dynamics between Basotho men and women, knowledge of HIV and various related issues, including HIV testing, HIV treatment and discordancy in HIV status. Additionally, questions about knowledge and attitudes regarding traditional and medical male circumcision will be asked. Following the completion of the interview, the same facilitator will administer a brief survey to the study participant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of pregnant and postpartum women who have been tested for HIV
Using quantitative surveys conducted at the study sites, pregnant and postpartum women within 6 months of delivery will be asked if they have ever been tested for HIV.
Measured: 6 months
Secondary outcomes (2)
Percentage of index participants that live with their partner
To assess the feasibility of home-based testing, we will assess the percentage of pregnant and recently post-partum women that live with their partners.
Measured: 6 months
Percentage of male participants who have been circumcised
We will ask male participants if they have been circumcised to determine the feasibility and need for MC inclusion in future interventions.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startApr 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Time perspective
- Cross-sectional
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wafaa Mahmoud El-Sadr, Columbia University
- Investigators
- Wafaa M El-Sadr, MD/MPH, Principal investigator, ICAP-NY, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027714
- Sponsor's protocol ID
- AAAF0372
- Other IDs
- 1R01AI083038-01
- Acronym
- EPIC
- Status last verified
- Mar 2015
- First submitted
- 7 Nov 2013
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced HIV Prevention in Discordant Couples in Lesotho: Feasibility Study #1
- ClinicalTrials.gov ID
- NCT02027714
- Acronym / sponsor ID
- EPIC / AAAF0372
- Keywords
- Discordant, Lesotho, Couples, Enhanced Prevention Package (EPP), ART, Counseling, Male Circumcision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 Jan 2014 (estimated)
- 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 purpose of this study is to gather information needed to develop a large prevention trial to decrease the risk for HIV transmission among HIV-discordant couples (where one person is HIV-positive and the other is HIVnegative) in Lesotho. The protocol team would like to learn more about men, women and couples in Lesotho and what they think about various topics related to HIV, including HIV testing and counseling, male circumcision and HIV treatment.
There will be three parts to the study including 1) a survey 2) focus group discussions; and 3) in-depth interviews. Two hundred pregnant or recently postpartum women will be recruited to participate in the survey. Women who answer the questionnaire will also be asked to participate in the focus groups. A total of 6-8 groups consisting of 6-12 women each will be conducted. Thirty men from the community will be recruited to participate in an in-depth individual interview.
Detailed description
Studies to date indicate that HIV negative partners within HIV-discordant couples (where one partner is HIV+ and the other is HIV-) are at substantial risk of acquiring HIV infection and that such transmission may play animportant role in heterosexual transmission of HIV in countries with high seroprevalence in sub-Saharan Africa. The purpose of this study is to conduct preparatory research needed to design and implement an HIV-prevention intervention trial aimed at decreasing the risk for HIV infection among HIV-discordant couples in Lesotho.
Using both quantitative and qualitative research methods, the study aims to:
- Establish baseline characteristics of the proposed study population, specifically pregnant and recently postpartum women and of men in Lesotho
- Explore the types of sexual and social relationships that exist between men and women in Lesotho
- Assess individual knowledge, understanding and perceptions around different HIV prevention strategies, including HIV testing and treatment, couples counseling and male circumcision
- Identify interpersonal and individual-level barriers to accessing these types of HIV prevention interventions.
There will be three study components including 1) quantitative survey 2) focus group discussions; and 3) in-depth individual interviews. A quantitative cross-sectional survey will be administered to 200 pregnant and recently postpartum women. Qualitative components will be based on open-ended iterative inquiry via focus group discussions and in-depth interviews with two groups: (1) pregnant and recently postpartum women; and (2) men. Data gathered during this study will inform the study design and intervention components of the proposed prevention intervention study.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Women's Quantitative Survey | – | –Quantitative surveys will be administered to 200 pregnant and recently postpartum women. Surveys will be conducted in either English or Sesotho depending on the participant's preference. Surveys will be administered by a study-staff member. Survey activities will be conducted in a private space either within or around the clinic building. All study activities will take approximately 1 hour to complete. The survey is comprised of 62 close-ended questions. Included in this survey are questions related to demographics, sexual behaviors, HIV and various HIV testing services. |
| Women's Focus Group Discussions | – | –6-8 focus groups of approximately 6-12 pregnant or recently postpartum women will be conducted. Focus group discussions will be organized according to HIV serostatus to allow for open dialogue and participant comfort. All group discussions will be conducted in Sesotho. Each group discussion will be facilitated, preferably, by a female study-staff member. All group discussions will be held in a private space either within a study site or another specified location within the community. All study activities will take approximately two hours to complete. Topics that will be discussed during these interviews include relationship dynamics between Basotho men and women, knowledge of HIV and various related issues, including HIV testing, HIV treatment and discordancy in HIV status. Additionally, questions about knowledge and attitudes regarding male circumcision will be asked. |
| Male Interviews | – | –30 in-depth individual interviews with men. In-depth semi structured interviews consisting of open-ended questions will be conducted in either English or Sesotho depending on the participant's preference will be conducted. Interview activities will be conducted in a private space either within or around the clinic building. Topics that will be discussed during these interviews include relationship dynamics between Basotho men and women, knowledge of HIV and various related issues, including HIV testing, HIV treatment and discordancy in HIV status. Additionally, questions about knowledge and attitudes regarding traditional and medical male circumcision will be asked. Following the completion of the interview, the same facilitator will administer a brief survey to the study participant. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant and postpartum women within 6 months of delivery and men will be enrolled. This feasibility study is targeting women seeking care in ANCs as these clinics are where large numbers of women learn their HIV status and become engaged in HIV prevention and/or care and treatment services. It is through these women that men from the community will be recruited for participation in the study.
Key inclusion criteria (15 listed)
- Women's Quantitative Survey
- Women at least 18 years of age
- Pregnant or within 6 months postpartum
- Receiving antenatal care at target clinic
- Ability to speak English or Sesotho
Key exclusion criteria (4 listed)
- Individuals meeting any of the exclusion criteria will be excluded from study participation.
- For all quantitative and qualitative components
- Individuals who do not meet the inclusion criteria outlined above
- Any condition which in the opinion of the investigators would interfere with adherence to study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent of pregnant and postpartum women who have been tested for HIV
Time frame: 6 months
Using quantitative surveys conducted at the study sites, pregnant and postpartum women within 6 months of delivery will be asked if they have ever been tested for HIV.
2 secondary outcomes
Percentage of index participants that live with their partner
Time frame: 6 months
Percentage of male participants who have been circumcised
Time frame: 6 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 24 Mar 2015.
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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.
Wafaa M El-Sadr, MD/MPH principal investigator
ICAP-NY, Columbia University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS), run by Columbia University at 4 sites in Lesotho.
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 15 inclusion and 4 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 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Lesotho. 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?
Percent of pregnant and postpartum women who have been tested for HIV (time frame: 6 months). 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 24 Mar 2015.