Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02964169 |
| Other study ID # |
10/08-16 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2016 |
| Est. completion date |
June 2018 |
Study information
| Verified date |
April 2021 |
| Source |
Mbarara University of Science and Technology |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Supporting HIV positive women to delay or prevent an unwanted pregnancy may improve women's
health through family planning choices, regular health reviews, and support. A cohort study
that was done in Mbarara amongst HIV-infected women documented 50% of the enrolled women
having no desire for a (another) child during the 4 years since ART initiation, 51% had a
serodiscordant partner, with only 45% using effective contraceptive method. Key predictors of
contraceptive use were family planning goals within the DYAD. One of the key predictors of
effective contraceptive use was male partner involvement and CD4 count. The WHO recommends
dual contraception (use of condoms and a hormonal or permanent method) to prevent both HIV
transmission and unwanted pregnancies (WHO,2014).This prospective intervention study aims at
providing information on whether continuous family planning accessibility and support has a
measurable impact on pregnancy intentions and contraceptive usage among postpartum HIV
positive mothers delivering at MRRH, SW Uganda.
Description:
HIV status and availability of ART have been found to widely influence the desirability and
expectations to have children among childbearing women living with HIV (Nieves et al., 2015;
Kaida et al., 2011). Up to 85% of the pregnancies within 3 years following ART are often
unwanted, often leading to illegal abortions and maternal deaths (Desgrees-Du-Lou et al.,
2002).
Uganda's HIV epidemic has declined over time to about a sero prevalence of 7.2% and this
decline has been attributed in part to improved prevention behavior like condom use,
reduction in multiple concurrent partnerships and other strategies to prevent unwanted
pregnancies. Specifically, HIV prevalence is estimated at 7% among women attending antenatal
clinics in Uganda (UN, 2010). Whereas ART availability has improved general health outcomes
through viral load suppression and immune reconstitution, there is still a high unmet need
for family planning among HIV positive women in Uganda (Snow et al., 2011), where modern
contraceptive prevalence is at 33% in the general population despite the widespread
promotional messages across the country. This continues to expose HIV positive women to
increased risks of unwanted/unplanned pregnancies, perinatal HIV transmission, pregnancy
complications, and increased economic burden of care for self and others among others.
The high average fertility rate of 5.9 children per woman in Uganda may further complicate
the immunity and wellbeing of the already burdened HIV positive women and their families even
amongst those already accessing HIV care (Muyindike et al., 2012; Homsy et al., 2009).
Supporting HIV positive women to delay or prevent an unwanted pregnancy may improve women's
health through family planning choices, regular health reviews, and support. A cohort study
that was done in Mbarara amongst HIV-infected women documented 50% of the enrolled women
having no desire for a (another) child during the 4 years since ART initiation, 51% had a
serodiscordant partner, with only 45% using effective contraceptive method. Key predictors of
contraceptive use were family planning goals within the DYAD. One of the key predictors of
effective contraceptive use was male partner involvement and CD4 count. The WHO recommends
dual contraception (use of condoms and a hormonal or permanent method) to prevent both HIV
transmission and unwanted pregnancies (WHO,2014).This prospective intervention study aims at
providing information on whether continuous family planning accessibility and support has a
measurable impact on pregnancy intentions and contraceptive usage among postpartum HIV
positive mothers delivering at MRRH, SW Uganda.
General objective To test the effect of a family planning availability and support
intervention on pregnancy intentions and use of effective contraception among recently
postpartum women living with HIV who delivered at MRRH.
Specific objectives
1. To assess the influence of the intervention on pregnancy intentions among recently
postpartum HIV positive mothers delivering at MRRH, SW Uganda one year after the
intervention.
2. To assess the impact of the intervention (voucher) on contraceptive uptake among
recently postpartum HIV positive mothers delivering at MRRH, SW Uganda
3. To assess the influences of the intervention (SMS +Partner involvement) on contraceptive
uptake among recently postpartum HIV positive mothers delivering at MRRH, SW Uganda
4. To identify factors that influence pregnancy intentions and contraceptive use
5. To assess the influence of the intervention on the incidence of unintended pregnancy
among recently postpartum HIV positive mothers delivering at MRRH, SW Uganda
6. To explore decision making challenges and perceptions of family planning among HIV
positive women.
7. To assess the role of sexual partners on pregnancy intentions and effective
contraceptive use
Methods This will be a prospective randomized controlled trial of 2 arms. I. The
investigators intend to enroll a total of 320 HIV positive women delivering at MRRH. The
participants will be equally randomized into the intervention arm (Family planning support)
and control group (no family planning support, except the routine counseling following
discharge). These women will be followed for 1 year. Their male partners will also
voluntarily choose to participate in the study or not. Eligibility will also require access
to a mobile phone.
II. Intervention group. Following delivery, the participants will be given a voucher to
freely access any of the five family planning options of their choice. A voucher will also be
given to the spouse/sexual partner due to its identified effect on family planning
utilization (Ashraf et al., 2014). Although family planning is already free, there are
usually stock outs. The voucher will therefore be an incentive to access the family planning
timely (maximum of 1 hour waiting time) and continuously from the study in case of stock
outs. These include; condoms (40 condoms), injectables, contraceptive pills, copper IUD and
contraceptive implants. The women will be contacted at 6 weeks postpartum for initiation of
family planning by a study nurse well trained in specialized family planning care and support
for HIV positive women if they have not done so yet. The choice of family planning will be
entirely up to the participants. For those women who select oral contraceptive pills, women
will be sent daily [adherence support] reminders for the first 4 months, then weekly
reminders (via SMS) for the next 4 month and then monthly for the next 4 months. This level
of SMS support has been found to have a positive impact on adherence (Haberer et al., 2016).
Sexual partners/regular spouses of women in intervention arm will also receive these
reminders weekly [but not daily or monthly] throughout the study. The reminders will also be
sent monthly if one chooses an injectable contraception [consider whether it's the 2-month or
3-month injectable] for the 12 study months. Daily reminders will also be sent for women who
choose male or female condoms. Routine reviews on family planning will be done for women in
the intervention arm alongside their routine visits at the HIV clinic or post-natal PMTCT
visits. Interviews with study participants will be done at baseline, 6 and 12 months
postpartum. The spouses/ sexual partners will be contacted, enrolled and interviewed at
baseline, 6 months and at 1 year.
III. Control group: These will be counseled on family planning at discharge and enrolled.
They will be interviewed at baseline, 6 months and 1 year. Data on reproductive history,
HIV/AIDS experience, socio-sexual relationships, fertility aspirations, use and knowledge of
family planning, decision making, and perceptions on Family planning, alcohol use, food
security, education, socio-economic, side effects or undesirable effects, economic and social
support will be documented.
Natural family planning methods like lactation amenorrhea, withdrawal methods and others have
been presented with mixed literature, painting a grim picture on their effectiveness as
standalone contraceptive methods especially among HIV positive women. All women are advised
to exclusively breast feed for 6 months while on ART (MoH, 2015). Because hormonal
contraception inclusive of estrogen interferes with breast milk production among lactating
mothers, progestin-only methods will be recommended to the women.
IV. Randomization:
Consecutive numbers ranging from 001 to 320 will be computer generated to indicate the 2 main
groups into which mothers can be randomly assigned and enrolled. These consecutive numbers
will be labeled on top of the opaque envelopes. To be eligible, mothers must be HIV positive,
have had a delivery within the last 48 hours, above 18 years of age, anticipating to begin
family planning at 6 weeks postpartum, must be mentally stable and qualify for any family
planning method available. Once eligibility of a mother is confirmed, they will be invited to
participate in the study.
The aim of the study and details of the procedures to be involved in the trial, potential
side effects and therapeutic benefits will be explained before randomization occurs. Once the
mothers consent to participate in the study, a study number will be allocated by the nurse
research assistant (who will be recruited to work on the ward/post natal clinic for this
study) by taking the next in a series of similar opaque envelopes provided to conceal
allocation of groups. These opaque envelopes will be labeled with computer-generated list of
numbers with group allocation (either Intervention group or Control Group) of the mothers
randomized in blocks of 20. Nurse research assistants will be blinded to the group allocation
until eligibility and study participation is confirmed. The research assistants will also be
blinded to hypothesis of the study.
A blood sample will be drawn at baseline to confirm the HIV status and or do a CD4 cell count
in case it is unknown at the time of enrollment. This will be done to support women enroll
for the recommended Option B+ in case the women are not yet lifelong ART].
A different study nurse will be enrolled and trained to specifically collect data from
participants. The socio-demographic data and obstetric characteristics will be documented.
Other documented potential covariates of contraceptive use like participant age, primary
partner's age, primary partner's HIV status, personal and partner fertility desires, number
of children, most recent CD4 cell count, Efavirenz-containing ART Regimen (due to its
association in decreasing levels of hormonal contraception thus recommending dual methods and
its teratogenicity concerns- although these concerns have been found to be exaggerated),
socio-economic status, body mass index, education level, time on ART . Prior contraceptive
use experiences, fertility desire/ pregnancy intentions or aspiration will be measured using
the CDC pregnancy Risk Assessment Monitoring System Instrument (Ahluwalia et al., 1999)
Effective contraception use will be defined as consistent use [both self report and
observational chart review from study nurse at the family planning clinic] of a family
planning method (including consistent condom use) , including dual contraception (use of
condoms and another contraceptive method-hormonal or permanent) for HIV-sero discordant
couples/partners (for participants who know partner's status). A primary partner will be
defined either as a regular spouse, who is also a regular sexual partner or the most recent
sexual partner if no main partner is named. These sexual partners will also be enrolled and
interviewed at baseline and at 1 year. In case a consented mother ends up with a serious
adverse event, the time and indication will be documented and reported. In case a woman
changes the contraceptive method, the reasons for the change will also be documented.
Data Preparation All data will be cross checked for completeness before entry. Data will be
coded and entered independently into the excel sheet and exported into STATA Version 12 for
statistical analysis. For each variable, a reference category will be identified.
Data Analysis Plan Data analysis will be by intention-to-treat (ITT) consisting of all
mothers randomized and thus supposed to be treated (Lesaffre, 2008). Descriptive statistics
will be used to describe key characteristics of study participants. Different variables will
be explored for normal distribution. Continuous variables will be compared with binary
outcomes of contraception effectiveness and pregnancy intentions using a t- test. Selected
demographic, clinical, post-natal factors will be compared for differences and similarities
in the three groups. Crude relative risks will be derived. Relative risks with 95% confidence
Interval (two tailed) will be calculated and used to compare contraception effectiveness and
pregnancy intentions in all groups. Factors associated with effective contraception use and
pregnancy intentions will be explored using univariate analysis and for results whose p value
≤ 0.10, a multivariate analysis will be done to rule out confounding factors.
Data Reporting The means will be presented with their standard deviations. Relative risks and
odds ratios will be presented with their 95% confidence Intervals. Two-tailed statistical
analysis will be used and statistical significance will be defined at level of p < 0.05.
